chrisvoncsefalvay/vaers-outcomes huggingface dataset:
body aches; low grade fever of 99.9°F (lasted 6-8 hrs); chills; fatigue; my arm felt like someone hit me with baseball bat; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (body aches), PYREXIA (low grade fever of 99.9°F (lasted 6-8 hrs)), CHILLS (chills), FATIGUE (fatigue) and PAIN IN EXTREMITY (my arm felt like someone hit me with baseball bat) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-May-2021, the patient experienced MYALGIA (body aches), PYREXIA (low grade fever of 99.9°F (lasted 6-8 hrs)), CHILLS (chills), FATIGUE (fatigue) and PAIN IN EXTREMITY (my arm felt like someone hit me with baseball bat). The patient was treated with IBUPROFEN at a dose of 600 milligram. At the time of the report, MYALGIA (body aches), PYREXIA (low grade fever of 99.9°F (lasted 6-8 hrs)), CHILLS (chills), FATIGUE (fatigue) and PAIN IN EXTREMITY (my arm felt like someone hit me with baseball bat) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant product details were provided.
Nose bleeds; This spontaneous case was reported by a consumer and describes the occurrence of EPISTAXIS (Nose bleeds) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001B21A and 037A21B) for COVID-19 vaccination.     Concurrent medical conditions included Fish allergy (Helibut) and Hay fever.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced EPISTAXIS (Nose bleeds). At the time of the report, EPISTAXIS (Nose bleeds) had not resolved. Not Provided          No concomitant medication was provided by reporter. No treatment information was provided by reporter.   This case was linked to MOD-2021-333301 (Patient Link).
Patient complained of dizziness, cleared by EMS.  Instructed patient to call PCP, 911, or go to the nearest emergency room for any further issues.
The night of 4/1, 12 hours after vaccine, I woke up with a fever of 103 and was having muscle spasms in my arms and legs, and felt like my whole body was vibrating. My fingers were frozen, I could not feel them.   2 weeks later (last night) 4/15/21, I woke up feeling the vibrating sensation again. It feels like my whole body, muscles, everything are vibrating. I had muscle spasms in my arms and legs.
Patient was given the dose too soon. Patient received her first Meningococcal ACYW (Menactra) & Tdap on 7/8/2022 and then was given MedQuadFi & Tdap on 05/12/2023
pt vax heptaB.  3 days aft. pt devel redness and swelling at inject site.  treated w/ benadryl and reaction resolved w/i 7 days.
Immediate local reaction around injection site and on cheek w/ urticarial rash, swelling, erythema.  Next day developed more swelling, erythema, induration, pain around injection site. No respiratory distress, facial swelling, or other indicators of anaphylaxis noted.
Itchy skin, low grade fever, muscle pain, joint pain, extream thirst, fatigue
Information has been received from a health professional concerning females who were vaccinated with a dose GARDASIL (lot#'s not reported). Subsequently about 20% of the patients experienced pain after vaccination and returned late for their next dose. It was also mentioned that one patient complained her arm hurt the next day. The nurse did not have any specific patient information and would not estimate the total number of patients. Attempts are being made to obtain additional identifying information to distinguish the individual patients in this report. Additional information will be provided if available. Additional information has been requested.  10/08/08 This is in follow-up to report(s) previously submitted on 6/13/2008. Additional information was received. The nurse called to say that she did not have any idea how many patients experienced pain after vaccination or returned late for their next dose. She said that there was not one patient in particular who complained her arm hurt the next day. The nurse knows that these symptoms are possible side effects of the vaccination and that is what she tells the patients. No further information is expected.
3:20PM C/O TINGLING TO RT 5TH DIGIT. A/O, PINK, W/D, RESP REG WITH EASE. DENIES ANY SOB OR DYSPNEA. STATES SHE 'HAS BEEN NERVOUS ABOUT GETTING THE SHOT.'  4:12PM STATES 'SHE IS FEELING BETTER'. 3-3-2108:10AM TC PT STATES 'STILL HAS TINGLING TO RT 5TH DIGIT, HEADACHE & RT ARM IS NOW SORE. STATES SHE 'FEELS LIKE SHE IS PREOCCUPIED AS SHE WAS SO NERVOUS ABOUT GETTING THE SHOT'.  ADVISED TO F/U WITH HER PCP IF S/S CONTINUE. SHE STATES 'SHE MAY TAKE A TYLENOL TONIGHT AT BEDTIME.'
I have nausea, tiredness, headache, muscle pain, joint pain, feeling unwell, swollen lymph nodes.; I have nausea, tiredness, headache, muscle pain, joint pain, feeling unwell, swollen lymph nodes.; I have nausea, tiredness, headache, muscle pain, joint pain, feeling unwell, swollen lymph nodes.; I have nausea, tiredness, headache, muscle pain, joint pain, feeling unwell, swollen lymph nodes.; I have nausea, tiredness, headache, muscle pain, joint pain, feeling unwell, swollen lymph nodes.; I have nausea, tiredness, headache, muscle pain, joint pain, feeling unwell, swollen lymph nodes.; I have nausea, tiredness, headache, muscle pain, joint pain, feeling unwell, swollen lymph nodes.; This is a spontaneous report from a contactable consumer (patient). A 53-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on Apr2021 03:00 PM (Batch/Lot number was not reported) as 1ST DOSE, SINGLE for covid-19 immunisation. Medical history included prior to vaccination, the patient was diagnosed with COVID-19; had known allergies and other medical history. The patient had other medications received within 2 weeks of vaccination, name was unspecified. Reported Event: I have nausea, tiredness, headache, muscle pain, joint pain, feeling unwell, swollen lymph nodes. The events resulted in Emergency room/department or urgent care.  adverse event start date 27Apr2021, adverse event start time 03:00 PM. No treatment received for events. The Serious was reported as No. The event outcome was not recovered. Since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
SUSPECTED COVID-19; SLIGHTLY SWOLLEN UPPER LIP; This spontaneous report received from a patient via other manufacturer Pfizer concerned a 61 year old male of unspecified race and ethnicity. The patient's height, and weight were not reported. The patient was not on any other medications or products within 2 weeks of starting COVID-19 treatment. Patient had unspecified drug allergy. The patient previously received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (unspecified manufacturer) (suspension for injection, route of admin not reported, batch number: unknown and expiry: unknown) dose was not reported, 1 total, administered on an unspecified date for covid-19 prophylaxis. It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26. cov2.s (unspecified manufacturer) (Dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin not reported, batch number: unknown and expiry: unknown) dose was not reported, 1 total, administered on DEC-2021 for covid-19 prophylaxis. Age at time of vaccination 60 years old. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient had Covid-19 (suspected Covid-19) (Dose number in series 2) and received non company suspect paxlovid (form of administration and route of administration were not reported, batch number: 1919255A, expiry: unknown) dose was not reported, administered from 07-OCT-2022 till 08-OCT-2022 for covid-19 treatment. On 08-OCT-2022 at 01:00, the patient experienced slightly swollen upper lip (Dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable and paxlovid was drug discontinued on 08-OCT-2022. The patient was recovering from slightly swollen upper lip and the outcome of suspected covid-19 was not reported. This report was non-serious.
Increased shortness of breath,  slight sore throat, arm fatigue, injection site redness and warm feeling. Did not immediately understand the connection to the vaccine as I was already having a recent issue with shortness of breath from an unknown cause.  I experienced similar symptoms again on the second dose which led me to think it was more vaccine related.
After one week after the first Twinrix vaccine injection many small red bumps appeared on my hands arms and groin area. My skin then became rough and bumpy and quite itchy. Now at 10 weeks after many large blotches have formed on the chest, underarms, legs and groin areas. The ears and scalp area are very sensitive and itchy. It seems that the whole condition of the skin is very sensitive and often itchy.
Symptoms occurred a day post injection. Chills, increase in body temperature. Injection site erythema/swelling about 4 inches in diameter. Localized reaction, tender to the touch.
I began shaking from top of head to twos..teeth, hands knees a.  It was not like chills from being cold but an uncontrollable shaking.  After about 10 minutes my husband decided to take to me hospital but friend had called 911 and emt arrived
Patient C/O feeling warm, had a 102.4 fever; headache; bodyache; fatigue; hoarse voice; and nausea and vomiting. Patient also had arm pain at the site of injection. The patient took Advil for the fever and body aches.
red spots/on arms and legs; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 78 year-old female patient received bnt162b2 (BNT162B2), administration date Apr2021 (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: RASH MACULAR (non-serious) with onset Apr2021, outcome "unknown", described as "red spots/on arms and legs". Additional information: Patient had Pfizer Covid first dose "a week and a half ago" but did not remember the exact date. Then had red spots that she didn't have before, on arms and legs and she started to experience it this week (did not specify the date).   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report was received from a pharmacist regarding an unspecified patient of unknown gender. Information on pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On 30-MAR-2018, the patient inadvertently received an expired dose of ZOSTAVAX 19400 PFU, lot# N011366 with expiry date of 12-MAR-2018 subcutaneously for prophylaxis. The vaccine was reconstituted with sterile diluent lot# N006324 with expiry date of 24-JUL-2019. No adverse effect was reported. No product quality complaint was reported.
This spontaneous report as received from a physician via a company representative refers to a 10 year old female patient. The patient's medical history included Henoch-Schonlein purpura (HSP). On 05-JUL-2013 the patient was vaccinated with PNEUMOVAX23 (lot # H021941, expiry date 11-JUL-2014, intramuscular, dose was unknown). The patient received BOOSTRIX and HAVRIX on the same day as receiving the PNEUMOVAX23 but in the "other" arm. "Two days later" approximately on 07-JUL-2013, the patient developed cellulitis "below the injection site just above the elbow" and a fever after receiving PNEUMOVAX23. The outcome of events was unknown. The patient went to an unspecified emergency room on an unspecified date to seek medical attention and was given an unspecified sulfur drug. This is one of two reports received from the same source. Additional information has been requested.
After administration after a few minutes sitting in observation, patient informed pharmacist she was feeling dizzy.  Pharmacist gave her cold water and offered to take her blood pressure.  She agreed, result: 122/77 mmHg, 60 bpm at 11:10AM.  Patient started to feel better, pharmacist asked patient to continue to sit and wait and offered to call paramedics.  Patient refused and continued to just sit  and drink water.  After a little bit longer pharmacist re-checked patient and she was feeling much better and wanted to leave.  She denied tingling, feeling faint, vision changes. She was coherent the entire time and was able to answer pharmacist's questions.  Patient left unassisted.
This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 59-year-old female patient who received SHINGRIX (batch number HM3NC, expiry date 13th April 2021) for prophylaxis. On 10th December 2018, the patient received SHINGRIX (intramuscular). On 12th December 2018, 2 days after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the outcome of the shingles was not recovered/not resolved. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details were provided as follows: The patient developed a Shingles outbreak.
PT started developing abnormal symptoms the day after vaccination. He started with a migraine in the morning that lasted all day. He was light and sound sensitive. Into the night at around 1100p.m. he developed chills and night sweats, it is unknown if he was febrile, and was lethargic. The patient has a localized reaction at the site of injection, the site inflamed, erythema, and warm to touch. It was 5in in diameter.
Pt recvd vax 24JUL92 & immed following the vax pt devel a red local reaction described as silver dollar size & swelling @ the inject site; pt treated w/DPH & recovered; No further details were provided;
1/4 vaccination 1/5 Severe HA; extreme couldn't hold head.  1/6 Elevated BP 160/100 stayed for about 1 week; put on BP meds. Fatigue, joint pain; extreme. Could not stay awake.  Thursday I went to Dr. Administered BP meds.  Following week; Dr. Tested all inflammatory markers; elevated.  *waiting to have markers retested.  **missed 3 weeks of work.  ***still having joint pain. Hasn't resolved.
Pt has significant swelling and redness in her right arm between her shoulder and elbow. She reported itching and soreness as well.
unable to sleep or rest comfortably; cold; feeling like he couldn't breathe; felt like his chest was being compressed and was very restless; felt like his chest was being compressed and was very restless; This is a spontaneous report from a contactable consumer or other non-healthcare professional (patient). A 17-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EW0162), dose 2 via an unspecified route of administration, administered in Arm Left on 14Apr2021 at 11:45 (age at the time of vaccination was 17 years) as DOSE 2, SINGLE for covid-19 immunisation at Hospital. Medical history included occassional vasovagal syncope from an unknown date and unknown if ongoing and known allergies were reported as no. Concomitant medication(s) and other medications in two weeks included ibuprofen (ADVIL [IBUPROFEN]) and vitamins nos (FLINTSTONES) both taken for an unspecified indication, start and stop date were not reported. Historically the patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EP6955) via an unspecified route of administration, administered in Arm Left on 25Mar2021 at 11:30 (age at the time of vaccination was 17 years) as DOSE 1, SINGLE for covid-19 immunisation. Other vaccine in four weeks was reported as no. The patient did not have covid prior to vaccination. On n 15Apr2021 at 05:30, the patient was unable to sleep or rest comfortably, cold, feeling like he couldn't breathe and felt like his chest was being compressed and was very restless. It was reported that, the patient woke up in the middle of the night, cold, and feeling like he couldn't breathe. He felt like his chest was being compressed and was very restless. The chest compression scared him and caused him to be unable to sleep or rest comfortably. He has since recovered and was feeling better. The patient was not tested for covid post vaccination. The treatment for ae was not received. The outcome of all the events was recovered on an unspecified date in 2021.  No follow-up attempts are possible. No further information is expected.
Suspected vaccination failure; shingles; herpes like blisters also under arm/at bra line; pain under arm; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included losartan and evolocumab (Repatha).   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On 19-MAY-2023, an unknown time after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: shingles), vesicular rash (Verbatim: herpes like blisters also under arm/at bra line) and axillary pain (Verbatim: pain under arm). The outcome of the vaccination failure was unknown and the outcome of the shingles, vesicular rash and axillary pain were not reported.   It was unknown if the reporter considered the vaccination failure, shingles, vesicular rash and axillary pain to be related to Shingrix and Shingrix.   It was unknown if the company considered the vaccination failure, shingles, vesicular rash and axillary pain to be related to Shingrix and Shingrix.   Additional Information: GSK Receipt Date: 19-MAY-2023 The reporter was patient's sibling. The patient was vaccinated in 2021 with Shingrix, 2 doses administered 3-months apart. At the time of reporting, she reported her first case of shingles.  She presented with pain under arm and break out of herpes like blisters also under arm/at bra line. This case was considered as suspected vaccination failure since the details regarding the laboratory confirmation of shingles were unknown at the time of reporting.
Immediately following the second COVID shot in my left arm, I began experiencing numbness and tingling in my left arm. The pain would go to my funny bone area, and down my forearm to my middle finger. It feels exactly like when you hit your funny bone very hard. At times the pain is a discomfort and a tingling, but there are days when it is so sore I can't use the arm. The pain has been consistent for 3 weeks now.
Soreness at injection site, bruising, low grade fever, difficulty breathing, sore neck and back pain. If persists will be taking her to the emergency room.
Pt was given the Fluzone HD for 65 year old and above patients, but was not yet 65 years old. Pt did not feel any side effects or adverse reactions but was counseled on risk of getting higher dose of flu vaccine.
On the morning after receiving the shot I came down with severe pain throughout my body and especially in both hips, along with fatigue. I was basically unable to get out of bed for 48 hours when the pain subsided.
This spontaneous report was received from a nurse practitioner referring to multiple unspecified patients of unknown age. On an unknown date the patients were vaccinated with ZOSTAVAX. No adverse event was reported. Additional information is not expected.
This spontaneous prospective pregnancy report was received from a 24 year old female patient regarding herself. The patient had no pertinent medical history or drug allergies. On 20-MAY-2013, the patient was vaccinated with first dose of GARDASIL, (lot number, expiry date and route was not reported) and on the same was found to be 5 months pregnant. Approximate date of last menstrual period was 06-JAN-2013 and estimates date of delivery was on 13-OCT-2013. There was no concomitant medication reported. The patient sought medical attention. Additional information has been requested.
Swelling, rash under L & R arm pit. Rash on chest. Head itching. R arm had muscle pain and shoulder sore. Headache all day Sat & Sun. Felt like had the flu both days.
I got COVID-19, it started with a sore throat, and cough. I was very fatigued. I reached out to a doctor on 12/26.
Dizziness, Weakness, Sores in mouth and lips, large red spots and sores all over back, head, neck, chest, small red blisters on bottom of feet. Problems breathing, pain in lungs, coughing. Treatment was cortisone cream, antibiotic ointments, antifungal creams, steroids, antibiotic oral, PROVENTIL albuterol sulfate inhalation aerosol. I have photos of my back. I still have sores in my mouth and lips and have had severe constipation; am eating lots of fruits and veggies.
COVID-19; This spontaneous report received from a consumer via a company representative from social media concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included: lupus. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. Concomitant medications included hydroxychloroquine for lupus. On an unspecified date, the patient experienced covid-19. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of covid-19 was not reported. This report was non-serious. This report was associated with a product quality complaint: 90000217514.
Vaccine administration error.  It is suspected the a 1/2" needle syringe was used instead of a 1" needle syringe.
This spontaneous report was received from a male consumer of an unknown age referring on himself. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 06-MAR-2017, the patient was vaccinated with PNEUMOVAX23 (administered in arm; dose, route of administration, lot # and expiration date were not reported). 4 hours after vaccination, the patient started to experience pain in the muscles in the arm where the vaccine was administered and his arm "hurt". The outcome of the adverse events and causality between the events and PNEUMOVAX23 were not reported. The product quality complaint was not involved. Additional information has been requested.
Patient received two i.m. vaccinations, RD = Tdap, LD = MENACTRA, after placing a band aid over injection site within a few minutes (R) deltoid showed dark pink, irregular rash, approx. 2 x 2 inches, non itchy.