chrisvoncsefalvay/vaers-outcomes huggingface dataset:
had redness; swelling; This non-serious case was reported by a physician via sales rep and described the occurrence of erythema in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced erythema (Verbatim: had redness) and swelling (Verbatim: swelling). The outcome of the erythema and swelling were not reported.   It was unknown if the reporter considered the erythema and swelling to be related to Shingrix.     It was unknown if the company considered the erythema and swelling to be related to Shingrix.   Additional Information: GSK receipt date: 27-JUL-2023 It was reported that patient upon receiving both her doses of Shingrix, had redness and swelling afterwards. No other information reported. The reporter did not consent to follow up. For tolerance of 2nd dose, refer case US2023AMR103388, reported by same reporter.; Sender's Comments:  US-GSK-US2023AMR103388:
Case number PHEH2013US022215, is an initial spontaneous report received from a pharmacist on 18 Oct 2013 and follow up report from the pharmacist received on 22 Nov 2013. This report refers to a 12-year-old male patient. On 10 Oct 2013, the patient was accidentally vaccinated with only 0.5 ml MenCYW-135 liquid component of MENVEO (batch number: A11078) intramuscularly and did not receive Men A lyophilized conjugate. It was reported that the patient did not experience any adverse event after the mal-administration. No other information was available. Follow up report from the pharmacist received on 22 Nov 2013: The report type changed from other to spontaneous. The patient details and MENVEO details were updated. The event changed from wrong solution used in drug reconstitution to inappropriate preparation of medication.
deaths occurred after Pfizer vaccine; This is a spontaneous report from a non-contactable consumer. This consumer reported similar events for 5 patients, this is the forth report. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via unspecified route single dose for COVID-19 immunization on an unspecified date. The patient medical history was not reported. The patient's concomitant medications were not reported. Patient died after Pfizer vaccine. It was reported that couple of deaths occurred after Pfizer vaccine, some of them immediately, some in few hours. The reporter stated that in one village with 2000 population, 5 death happen and some after the 2nd vaccine and one of them immediately after vaccine, The vaccine was kept in ice box for like 5 hours, other village it just about 3, another village or 2. The reporter asked if the vaccine was carried by just ice for like 5 hour, may be this was the problem.  Outcome of the event was fatal. The patient died on an unspecified date. It was unknown if an autopsy was performed.       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-202100944572 same reporter/drug/event, different patient; Reported Cause(s) of Death: deaths occurred after Pfizer vaccine
Patient reported pain in left arm after receiving Covid Vaccine. Injection was given in upper left, outer area (backside) of patient's shoulder. Patient also complained of numbness in hand. Patient was able to move his arm above his head and open and close his hand. He stated that the numbness was resolving after a short time and that he no longer felt pain in his lower left arm but only in his upper left arm. He continued to move his arm freely even though it was painful for him as well. After consultation,  I advised him to seek urgent care from DH if his symptoms were to worsen or not resolve or if he felt he needed to be seen by a MD.
Local reaction, swelling redness pain on (L) shoulder, posterolateral, site of subcut. Varicella inoculation 2 1/2 inch diameter.
This case was reported by a pharmacist and described the occurrence of injection site pain in a 19-year-old female patient who received BEXSERO. On 16th August 2017, the patient received the 1st dose of BEXSERO. On 16th August 2017, immediately after receiving BEXSERO, the patient experienced injection site pain. On 17th August 2017, the patient experienced numbness of extremities and injection site bruising. On an unknown date, the outcome of the injection site pain, numbness of extremities and injection site bruising were not recovered/not resolved. The reporter considered the injection site pain, numbness of extremities and injection site bruising to be probably related to BEXSERO. Additional details were provided as follows: The patient received the BEXSERO vaccine in the left upper arm. Less than a day after vaccination, the patient complained of pain at injection site since she had received the injection. On 17th August 2017, 1 day after vaccination, the patient woke up in the morning with numbness in left arm below the elbow and left hand. The patient also had slight bruising at injection site. The reporter did not want the physician to be contacted regarding these events.
Pt developed local rxn /w swelling & pain in rt arm & had T (but not measured).Pt developed hives & itching on neck & arms & also a fever blister.
Fever, joint pain, back pain, headache Took 800 mg of ibuprofen twice with some symptom relief
Vaccine administration at 1230; Tightening/itching of throat @ 1242; Benadryl 25mg/10mL administered at 1242; symptoms resolved shortly after
Patient presented to pharmacy and stated she had a red area at the site of her ZOSTAVAX immunization on 6-12-12. She was immunized on 6-11-12 by Rph. I instructed patient to notify her physician and see him if necessary. Patient saw her physician and returned to pharmacy with instructions for hydrocortisone scream, BENADRYL and EPIPEN. She was consulted extensively on the use of EPIPEN. She return to pharmacy again on 6-14-12 with a prescription for KEFLEX and instructions to use ZANTAC otc by rph on duty on 6-14-12 stated that the red area had spread to patients elbow. The red area on 6-12-12 was approximately 1" by 3" at site of injection.
This spontaneous report Was received from a 28 year old, male patient and refer to himself refers. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 23-FEB-2018, the patient was vaccinated with GARDASIL 9 lot # N020138 (formulation, strength, dose, frequency, route of administration, were not reported) for prophylaxis. No adverse event was reported. The outcome of the event was unknown.
Extreme exhaustion / fatigue; diarrhea; pain an swelling around injection site radiating to right shoulder blade; pain an swelling around injection site radiating to right shoulder blade; pain an swelling around injection site radiating to right shoulder blade; difficulty breathing; This is a spontaneous report from a contactable consumer (patient).  A 55-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EN6202), via an unspecified route of administration, administered in right arm on 13Mar2021 at 09:30 (at the age of 55-years) as dose 1, single for covid-19 immunization at a hospital. The patient medical history included diabetes mellitus, hypertension. The patient was not pregnant at the time of vaccination. The patient had known allergies to drug metronidazole. The patient had not received any other vaccine within 4 weeks. The patient had received other medications in two weeks (unspecified). On 13Mar2021 10:45 the patient had experienced extreme exhaustion / fatigue, diarrhea, pain an swelling around injection site radiating to right shoulder blade, difficulty breathing. The patient received no treatment for the event. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. The outcome of the events was recovering on an unspecified date.   No follow-up attempts are possible. No further information is expected.
Around 8pm, following the injection, my arm got incredibly painful and my ROM was extremely limited. I was unable to lay on my left side for five or six nights. My ROM has since improved some, but there is still a lot of pain, especially when trying to dress, holding anything heavy, or driving. Sleep is still poor. I am in pain nearly three weeks later.
Bad body ache; Sweating; fever-101; Bad chills; Fatigue; This spontaneous case was reported by a patient and describes the occurrence of PAIN (Bad body ache), HYPERHIDROSIS (Sweating), PYREXIA (fever-101), CHILLS (Bad chills) and FATIGUE (Fatigue) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003A21A and 12L200) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Mar-2021, the patient experienced PAIN (Bad body ache), HYPERHIDROSIS (Sweating), PYREXIA (fever-101) and FATIGUE (Fatigue). 05-Mar-2021, the patient experienced CHILLS (Bad chills). At the time of the report, PAIN (Bad body ache), HYPERHIDROSIS (Sweating), PYREXIA (fever-101), CHILLS (Bad chills) and FATIGUE (Fatigue) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Mar-2021, Body temperature: 101.         Concomitant medications taken by the patient were not provided. Treatment information was not provided. Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to US-MODERNATX, INC.-MOD-2021-024145, US-MODERNATX, INC.-MOD-2021-023982, US-MODERNATX, INC.-MOD-2021-068189 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-024145:hushand first dose case US-MODERNATX, INC.-MOD-2021-023982:wife (First dose case) US-MODERNATX, INC.-MOD-2021-068189:wife (second dose case)
On 8 Nov 2006, at ~10:00 AM I received a free dose (I.M.) of infuenza vaccine administered by our Health Services department.  At ~8:30PM, the same day, I gean ito experience chills which manifested into uncontrollable shaking of my entire body.  This lasted for approximalety 2 hours.  I had no fever at that time.  The shaking subsided and I was able to go to sleep.  The next morning I awoke with a sever headache, 101.5 fever, muscles aches, and extreme lethargy. I said home and slpet most of the day.  pain killers did not help my feveror headache.  I couldn't eat any food.  The next day, Friday, 10 November 2006, I had the same symptoms.  i went to my docutor who agrred that it appreaded that I had vaccine-induced flu.  I also began to get diarrhea on this day. I started alternating my pain meds and that helped my headache and my fever started to come down.  By Sunday, 12 November 2006, I was able to begin taking solid foods.  I returned to work on 13 November 2006 but in a very lethargic state.  I still have some of the effects of this event.
Lives alone at an assisted living facility. Patient presents to the ED secondary to failure to thrive.  Recently diagnosed with COVID.  Patient reports decreased p.o. intake.  Patient reports inability to walk secondary to severe weakness.  Labs done at the Hospital Emergency Department revealed elevations of her BUN and creatinine, which measured 33 and 1.62 respectively.  Her white blood cell count is elevated to 70,400 with a left shift on the differential count.  Her hemoglobin measured 9.7 g percent with hypochromic RBC indices, platelet count measured 694,000.  A chest x-ray was done showing bibasilar opacities which could represent developing pneumonia.  She is also noted to have a moderate-sized left pleural effusion.  The decision was made to admit her for further evaluation and management.  She will be treated with IV antibiotics appropriate for healthcare-associated pneumonia.  She is not presently hypoxic, so there is no indication for IV steroids at this time. Pulmonary Medicine, Infectious Diseases will be consulted. 5/20 Diagnosed with  Health-care associated pneumonia (gram-negative organism suspected.  Acute COVID-19 viral infection.  Left pleural effusion.  5/21 The fluid removed at the time of her left thoracentesis is a transudate--Pulmonary Medicine feels she likely developed the pleural effusion because of congestive heart failure.  She is still quite weak. 5/23 Patient continues to breathe comfortably.  She is awaiting discharge arrangements. Discharged
Headache and body aches since Wednesday; Headache and body aches since Wednesday; This is a spontaneous report from a contactable consumer (patient). This 52-year-old female patient received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EN608) via an unspecified route of administration on 10Mar2021 at 10:30 (at the age of 52-years-old) as a single dose in the right arm for COVID-19 immunization. Medical history included attention deficit hyperactivity disorder and seasonal hay fever. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications included dextroamphetamine sulfate, trazodone, and spironolactone from unspecified dates for unspecified indications. The patient previously received penicillin, amoxicillin, sulfa, ciprofloxacine (CIPRO), and oxycodone hydrochloride, paracetamol (PERCOCET) from unknown dates for unknown indications and experienced allergy. The patient also had allergies to dust mites and hazelnuts. On 10Mar2021 at 12:00 the patient experienced headache and body aches since Wednesday (10Mar2021). The events were reported as non-serious. The patient was not hospitalized for the events. The patient received treatment with acetaminophen, ibuprofen (ADVIL), and naproxen. The outcomes of headache and body aches were not recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
Temp 101.7, chills, sore throat, stuffy nose, achy, wheezy when taking in a full breath of air
Had Dtap/IPV vaccine on 6/4/07. Pt after 5 days had bad cellulite reacting on Right arm. Ordered to hospital and put on IV antibiotics.
A report has been received from a Physician concerning a 4 year old, female patient. The relevant history and concomitant drugs of patient were not reported. The patient had been receiving nasal FLUMIST which was started on 22-Jan-2013. The physician reported that the patient had flu-like symptoms on 24-Jan-2013. The symptoms included body ache, fever, congestion and cough. At the time of reporting, the event of flu-like symptoms was continuing. The reporter considered the event of flu-like symptoms to be non-serious.
couldn't do much of anything; fever; This spontaneous case was reported by a consumer and describes the occurrence of MOBILITY DECREASED (couldn't do much of anything) and PYREXIA (fever) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Patient had no COVID + test or diagnosis.  Concurrent medical conditions included Nasal allergy and Skin cancer. Concomitant products included METOPROLOL, ATORVASTATIN, ACETYLSALICYLIC ACID (ASPIRIN 81), FISH OIL, MULTIVITAMIN [VITAMINS NOS], VITAMIN D [VITAMIN D NOS], ARGININE, HISTIDINE, ISOLEUCINE, LEUCINE, LYSINE, METHIONINE, PHENYLALANINE, THREONINE, VALINE (CREATE [ARGININE;HISTIDINE;ISOLEUCINE;LEUCINE;LYSINE;METHIONINE;PHENYLALANINE;THREONINE;VALINE]) and CREATINE MONOHYDRATE for an unknown indication.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MOBILITY DECREASED (couldn't do much of anything) and PYREXIA (fever). At the time of the report, MOBILITY DECREASED (couldn't do much of anything) and PYREXIA (fever) outcome was unknown.            Concomitant medications included Create (D) No treatment was reported   This case was linked to MOD-2022-580263, MOD-2022-580265, MOD-2022-580267 (Patient Link).
Pt said he was disoriented , lightheaded and dizzy. We had him sit to observe him. He was flushed all over body and cold to touch. He stated he was feeling nauseous. I led him to a private space and had him lie down. He stated that his lips were tingling.  I gave him 25mg liquid diphenhydramine and continued to observe. He said throat was very dry and feeling worse. I contacted 911 and they came to the clinic to evaluate the patient. They checked blood pressure, blood sugar, heart rate and rhythm. At 5:25 he decided he was feeling a little better and he refused transport by the ambulance. We arranged for an emergency contact to come pick him up.
my left arm was very sore/tight; my left arm was very sore/tight; my entire left arm is weak; My left hip and left knee are sore; My left hip and left knee are sore; I am very weak; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Jul2022 at 15:00 as dose 1, single (Lot number: FP7139) at the age of 75 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Tore my tendons right shoulder" (unspecified if ongoing), notes: Tore my tendons right shoulder; "hurt" (unspecified if ongoing), notes: hurt; "Known allergies: Sulfa products ivp dye" (unspecified if ongoing), notes: Known allergies: Sulfa products ivp dye; "Known allergies: cat dander" (unspecified if ongoing), notes: Known allergies: cat dander. There were no concomitant medications. The following information was reported: ASTHENIA (non-serious) with onset 08Jul2022 at 15:00, outcome "not recovered", described as "I am very weak"; ARTHRALGIA (non-serious), ARTHRALGIA (non-serious) all with onset 08Jul2022 at 15:00, outcome "not recovered" and all described as "My left hip and left knee are sore"; MUSCULAR WEAKNESS (non-serious) with onset 08Jul2022 at 15:00, outcome "not recovered", described as "my entire left arm is weak"; PAIN IN EXTREMITY (non-serious), MUSCULOSKELETAL STIFFNESS (non-serious) all with onset 08Jul2022 at 15:00, outcome "not recovered" and all described as "my left arm was very sore/tight". The events "my left arm was very sore/tight", "my entire left arm is weak", "my left hip and left knee are sore" and "i am very weak" required physician office visit. Therapeutic measures were not taken as a result of pain in extremity, musculoskeletal stiffness, muscular weakness, arthralgia, arthralgia, asthenia.  Additional information: This report was assessed as non serious. The patient did not receive any other vaccine within four weeks. Immediately after the patient received the vaccine her left arm was very sore/tight. That night it was really very sore and hurt and continued to hurt. Now her entire left arm was weak and hurt. She was very weak. Her left hip and left knee were sore. Prior to vaccination, the patient was not diagnosed with COVID. Post vaccination the patient had not tested for COVID.
pt recv vax 28JUN95 c/o pain 2" below inj site, hard knot inj site, site warm to touch; but no redness or swelling; reports pain is getting worse daily instead of decreasing; 30JUN pt reports improvement, on meds
It was determined at the end of the day that the vaccination administered was expired (punctured he previous day).
Fever; rash; vaccine given beyond expiration date; This is a spontaneous report received from a contactable reporter(s) (Nurse) from medical information team.  A 61-year-old female patient received BNT162b2 (BNT162B2), on 18Apr2022 as dose 4, (booster) single (Lot number: FK9729, Expiration Date: 23Mar2022) at the age of 61 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: coviD-19 vaccine (DOSE 3, Manufacturer unknown, Third shot: 29Sep2021, NDC: 59267-1000-1, LOT: EW0183, EXP: 30Nov2021), administration date: 29Sep2021, when the patient was 61-year-old, for COVID-19 Immunization; coviD-19 vaccine (DOSE: 2, Second Dose: 29Jan2021, LOT: EL0140, NDC, EXP: Unknown, Manufacturer unknown), administration date: 29Jan2021, when the patient was 60-year-old, for COVID-19 Immunization; covid-19 vaccine (DOSE: 1, First Dose: 8Jan2021, LOT: EL0140, NDC, EXP: Unknown, Manufacturer unknown), administration date: 08Jan2021, when the patient was 60-year-old, for COVID-19 Immunization.  The following information was reported: EXPIRED PRODUCT ADMINISTERED (non-serious) with onset 18Apr2022, outcome "unknown", described as "vaccine given beyond expiration date"; PYREXIA (non-serious), outcome "unknown", described as "Fever"; RASH (non-serious), outcome "unknown".  Additional information: She was notified yesterday (24May2022) by a health department that some doses of Pfizer-BioNTech COVID-19 Vaccine (orange cap) were expired. The original expiry date that they were told was 31May2022 and then they were notified that the real expiry date was 05May2022. The manufacture date of these vaccines printed on the vial was Sep2021.The vaccines were being stored in a refrigerator since 24Feb2022. According to the 10 week storage time and according to the caller, the expiry date would be 05May2022. Then, a dose of this vaccine was administered on 06May2022. Caller wanted to know if the vaccine could still be used. RA e-transmitting potential AE duplicate. She declined to be transferred this time, since she had no additional details to add. She also mentioned that she was among the patients that received the expired gray cap vaccine. She received a dose on 18Apr2022 and she had fever for 2 days. Suddenly during the call, caller was not able to hear me anymore. I could her hear but she could not.  Managed callback attempts as per attached "VR-Callback or Contact Attempts (v15.0)". Callback attempt #1: 25May2022, 10:22 AM. Able to reach (Name withheld) and continue the call. She was notified yesterday (24May2022) by a health department that some doses of Pfizer-BioNTech COVID-19 Vaccine (gray cap) were expired. The original expiry date that they were told was 31May2022 and then they were notified that the real expiry date was 23Mar2022.