chrisvoncsefalvay/vaers-outcomes huggingface dataset:
swelling, redness & pain 8-10hrs p/inject; cellulitis in lt arm;
Expected symptoms ended within about 24 hours from the shot. But 48 hours after the shot there was massive nerve pain in the (left) shoulder of the shot, the pain radiated throughout deltoid, chest, shoulder, neck on the left side.  This nerve pain lasted for about 36 hours and then dissipated (I know it was nerve pain because years ago i experienced something similar in the other shoulder for unrelated reasons).  But the shoulder was very sore and weak for 2 full weeks, during which i saw an orthopedist who diagnosed  bursitis caused by SIRVA.  For weeks afterwards the shoulder felt like it returned to normal .  However in the first 2 weeks of June my whole left arm began getting sore and tired. In midjune i noticed that my shoulder was atrophying and the front deltoid was not activating (my biceps was doing all the work).  Orthopedist ordered an EMG (June 29), which confirmed axillary nerve damage to anterior deltoid.  I?ve been doing physical therapy since mid June and as of today July 25th it is beginning to recover but it could take months to a year and may never fully recover.
This is a spontaneous report received from a contactable consumer or other non-HCP (patient), for a Pfizer sponsored program (159558). A 55-year-old female patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), on Mar 7, 2021, single dose, for COVID-19 immunisation. Medical history included lupus (unspecified if ongoing); thyroid disorder (unspecified if ongoing); fibromyalgia (unspecified if ongoing) and back pain (unspecified if ongoing). Concomitant medication included: Hydroxychloroquine for systemic lupus erythematosus; Tylenol for fibromyalgia and back pain. The patient developed a skin disorder (some small dots on her cheek which lasted a week), onset Mar 7, 2021, with outcome of recovered (Mar 14, 2021). No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Had one year injections. No fever present. Has received area on right thigh with lump in middle approx 5-6cm.
Fever 104 13 hours after vaccination. DTaP, Hib, PCV and Varivax. Simple febrile seizure ensued.
Rash, about 4-5 inches in diameter directly below/adjacent to injection site.
Fever started about 10 hours after injection. At 12 hours after injection could not move left arm without severe pain. It felt like the bones were bending. Fever went as high as 102.5 and stayed between 100.5 and 102. Tried to control it with ibuprofen and acetaminophen but neither seemed to have much affect. Moderate all over body aches that made it uncomfortable to move around. Left arm pain started to recede around 20 hours after injection but arm is still sore at 51 hours. Fever broke at 44 hours after injection.
Respiratory Distress (Patient presents with respiratory distress. Brought in by ambulance with patient on C-Pap. Patient states that he woke with SOB. Hx of COPD and CHF. Denies any chest pain. )
pt recvd vax 18OCT93 & 20OCT93 c/o feeling cold & achy; was very fatigued; had a severe h/a & fever of 100.5; r/o infect;
Twenty four hours s/p immunizations, pt developed fever and erythematous pinpoint papule eruption descending from face to proximal portion of lower extremities. She also developed tonsillar erythema and edema. Her rapid strept test was positive. She was treated with Amoxicillin with resolution of fever after 24 hours. Patient has not been seen after her initial follow up.  Scarlet Fever versus Acute reaction to immunization.
Patient came to pharmacy Sunday 8/8 complaining of sore arm with redness and swelling.  She came to me on Monday 8/9 and stated she had gone to the ER Sunday evening with redness, rash, itching, and swelling.  They released her and told her to follow up with PCP if no improvement or worsening.
Information has been received from a nurse concerning a 76 year old female with cholesterol high, hypertension, ventricular tachycardia, sinus tachycardia and urticaria chronic and a history of unspecified allergies to ACE inhibitors, sulfa, PROCARDIA and Rofecoxib (MSD, WAES # 0809USA03423) who on 25-FEB-2008 was vaccinated with ZOSTAVAX (Merck) (Lot # 659323/1613U) via SC route.  Concomitant therapy included INNOPRAN, simvastatin (MSD), and MICARDIS.  On 09-APR-2008, the patient visited the physician's office and stated that she had pain in her left arm since receiving the vaccine and her shoulder burns if she lays on her left side.  Point of tenderness at deltoid, treated with steroid injection for tendonitis and nerve palsy radial.  She stated injection did not help.  On 30-JUL-2008 she was seen stating she had deltoid muscle pain with some pain with reduction resistance.  Radial nerve conduction test and appointment with neurologist on 25-AUG-2008 showed mild bilateral carpal tunnel syndrome, more on right than left, with slightly prolonged latencies on right.  Patient called office on 04-SEP-2008 stating the pain is continuing.  Started on CELEBREX for 7 days and MEDROL dose pack.  Referred to orthopedist and had appointment on 06-AUG-2008, no report received, and another appointment for 17-SEP-2008.   Additional information has been requested.
This case was reported by a consumer via interactive digital media and described the occurrence of Guillain Barre Syndrome in a male patient who received Influenza vaccine. Co-suspect products included Whooping Cough Vaccine. On an unknown date, the patient received Influenza vaccine at an unknown dose and Whooping Cough Vaccine at an unknown dose and frequency. On an unknown date, an unknown time after receiving Influenza vaccine, the patient experienced Guillain Barre syndrome (serious criteria GSK medically significant). On an unknown date, the outcome of the Guillain Barre syndrome was unknown. It was unknown if the reporter considered the Guillain Barre syndrome to be related to Influenza vaccine. Additional details were provided as follows: The age at vaccination was not provided. It was reported that, within 12 days after receiving the whooping cough vaccine, the patient experienced the Guillain Barre syndrome and almost did not survive. It reporter stated that the consumers need to know about the possibility of contracting the Guillain Barre syndrome after receiving vaccination, especially with additional vaccination, such as the flu vaccine.
Patient is suffering with sore arm, neck,coughing/sneezing and sick feeling. Recommended taking a tylenol 325mg if needed
Heavy vaginal spotting; Cramping; This is a spontaneous report from a contactable Other HCP (patient reporting for herself).   A 32-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 16Sep2021 at 11:00 (Lot Number: 30130BA), at the age of 32 years old, as 1st single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient was not pregnant at the time of vaccination and at the time of the event. Prior to vaccination, the patient had not been diagnosed with COVID-19, and since the vaccination, the patient had not been tested positive for COVID-19. On 18Sep2021, the patient started having heavy vaginal spotting and cramping as well, continuing for 6 days in a row and still present at the time of the reporting. The patient had not recovered from the heavy spotting and cramping.  According to the reporter, the events were judged as a serious medically important event.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information available and a close temporal association  a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported event Spotting vaginal and Cramps menstrual.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
Information has been received from a physician concerning an 85 year old Caucasian female with no relevant medical history or illness at the time of vaccination who on 9/18/02 was vaccinated with a first dose of pneumococcal vaccine 23 polyvalent IM in the upper left arm (lot 641115/1159L). On 9/18/02 at 20:00, the pt developed marked redness, swelling, and pain at the injection site. The pt sought unspecified medical attention and was treated with antibiotics for supposed cellulitis. The pt subsequently recovered. The reporting physician felt that the pt's injection site swelling, redness, pain, and cellulitis were considered other medical events (OMIC). No additional info is expected.
pt recv vax 240PM 31DEC96 @ 7:42 1JAN97 vomiting, diarrhea & cramping cont;taking APAP;t99.4, body aches, chills, nausea;cont through 6JAN;h/a through 5JAN;
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48-year-old male patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Mar2023, outcome "unknown" and all described as "COVID 19 Treatment". This case was reported as non-serious. Therapeutic measures were taken as a result of drug ineffective, covid-19. Treated with PAXLOVID started from 16Mar2023. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Suspected vaccination failure; got shingles; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional details provided were as follows: The age at vaccination was not reported. The patient received both the two shots and still experienced shingles. This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Pt recv vax on 3/26/99; on 4/4/99 pt exp rash on head, trunk, extremities x 3 days, fever (100), malaise, joint pain, flu-like sx
patient tested positive for Covid after receiving the first dose; patient tested positive for Covid after receiving the first dose; This is a spontaneous report from a contactable consumer. This consumer reported similar events for 7 patients. This report is for 2nd of 7 patients.   A patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date were not reported), via an unspecified route of administration on an unspecified date at a single dose for Covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The consumer reported that patient tested positive for COVID after receiving the first dose of the vaccine on an unspecified date. The outcome of events was unknown.   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-2021045622 same drug/AE, different patient
My Daughter had the flu shot on the September 21st and had some of the normal pain some people get from it, but as the days went on she started complaining more and more about the site where she was injected at, she start experience chronic pain around the clock and having muscle spasms, in her arm, we tried hot/ice pack and pain relivers but pain and other systems never went away.
2-4,  11:00AM - Achy and blah.  Very light 'flu-like' feelings.  Some nausea, slight sinus pain / headache.                              Lasted throughout day and evening.                              Temp. 99.  Some small shots of pain up neck and in right shoulder.  Possibly not related. 2-5,  09:00AM - Temp. 96.3.  Still some light nausea, etc.          10:30AM -  Feeling basically OK.  Shot site was sore with some slight under arm lymph                                                    tenderness.  (2nd shot was very painful and burned, unlike 1st dose which was                               amazingly painless with very little shot site soreness, if any.)           04:00PM - Discovered rash around shot site.  Rash was blotchy, somewhat and about 4-5 inches in circumference.  Slightly itchy.  Rash continued through 2-10-21 with a bit of remanent through 2-12-21.
Patient reported having abdominal pain and shortness of breathe for two days. Patient was assessed over the phone by P.A. and it was recommended for patient to call 911 or go to the nearest emergency room to be assessed further. Patient refused to go to ER on 4/20/21 patient verbalized that he would go on 4/21/2021.
COVID 19 Treatment; COVID 19 Treatment (headache, cough and congestion); vaccine brand: Other, vaccine brand other: Moderna,vaccine administration date: 01Apr2022; This is a spontaneous report received from contactable reporter(s) (Other HCP) from product quality group. The reporter is the patient.  A 59-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 24Feb2021 as dose 1, single (Lot number: EN6198), in left arm, on 21Mar2021 as dose 2, single (Lot number: EN6208), in left arm and on 28Sep2021 as dose 3 (booster), single (Lot number: 30135BA) at the age of 58 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 01Apr2022 as dose 4 (booster), single (Lot number: 027L21A), in left arm and on 23Sep2022 as dose 5 (booster), single (Lot number: AS7163B), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hashimoto's" (unspecified if ongoing); "GERD" (unspecified if ongoing); "Known allergies: Penicillins" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE, start date: Mar2017; DOXEPIN, start date: Nov2018; RABEPRAZOLE, start date: Jan2003; ESCITALOPRAM, start date: Dec2017; PREMPRO, start date: Aug2016; VITAMIN B 12 [CYANOCOBALAMIN], start date: Sep2020; VITAMIN D3, start date: Jan2018; CALCIUM, start date: Jan2013.  The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 01Apr2022, outcome "unknown", described as "vaccine brand: Other, vaccine brand other: Moderna,vaccine administration date: 01Apr2022"; DRUG INEFFECTIVE (medically significant), outcome "not recovered", described as "COVID 19 Treatment"; COVID-19 (medically significant), outcome "not recovered", described as "COVID 19 Treatment (headache, cough and congestion)". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (unspecified date) Positive; (09Feb2023) Negative, notes: BinaxNOW COVID-19 Antigen Self Test. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: Patient took treatment for COVID 19 with Paxlovid from 02Feb2023 to 07Feb2023. The concomitant drugs Vitamin B12 and Vitamin D3 are from nature made brand and Calcium of Citracal brand. Reportedly, Paxlovid completed on 07Feb2023. Tested negative on BinaxNOW COVID-19 Antigen Self Test on 09Feb2023. Became symptomatic again on 11Feb2023 at 06:00 PM. Retested on same test and positive. Symptoms include headache, cough and congestion. Patient did not take any treatment for this.; Sender's Comments: Based on the available information in the case, an association between the reported events INTERCHANGE OF VACCINE PRODUCTS , DRUG INEFFECTIVE & COVID-19 and The suspected drug cannot be ruled out.
Swelling, induration and redness led to total upper arm swelling, cellulitis and bacterial skin infection. Saw doctor who rx'd Levofloxacin but the ER on 01/09/2016 for Vancomycin IV, cultures, etc.
This case was reported by a physician via call center representative and described the occurrence of injection site pain in a elderly patient who received Hepatitis A vaccine. The patient's past medical history included breast cancer. In February 2018 the patient received the 1st dose of Hepatitis A vaccine. On an unknown date, less than a year after receiving Hepatitis A vaccine, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown. It was unknown if the reporter considered the injection site pain to be related to Hepatitis A vaccine. Additional details were provided as follows: The age at vaccination was not reported. The patient reported that she had a Hepatitis A vaccine (unknown name) two months before the date of reporting, on Feb 2018, the first injection of two, and experienced right arm pain at the injection site. The patient was also a retired physician. The patient had denied permission to contact their physician. This case has been linked with US2018068933, reported by the same reporter for the same patient.
This case was reported by a consumer via call center representative and described the occurrence of sickness in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced sickness. On an unknown date, the outcome of the sickness was unknown. It was unknown if the reporter considered the sickness to be related to SHINGRIX. Additional information was provided as follows: The age at vaccination was not reported. The patient who was consumer friend got sick after getting a SHINGRIX shot. The reporter hung up before further information could be obtained.
pt recv vax 4MAY99 & w/in 1hr post vax pt face reddened & exp itching & throat was closing up;pt thought was exp anaphylaxis & ended up in ER;tx w/med;
Patient received 4 year boosters on 10/08/2003.  Patient come to office 10/10/2003 with large area of redness at site.  Site was also warm and tender.  Patient told to apply cool cloths and take Motrin.
Within 5 minutes after receiving vaccine, patient became hot, sweaty, dizzy and nauseous. While moving patient to counsel room, she went limb but did not pass out. 911 was called. Patient then threw up, continued to be dizzy and nauseous. Patient never experienced hives, rash, swelling of the throat or difficulty breathing. Continued to monitor patient for breathing until EMT arrived and took over care. EMT advised mom to either take her to hospital by ambulance or herself or to monitor her at home. Mother took her to hospital herself.
Received the vaccine at 8:30am this morning and at around 6pm same day started feeling feverish and tired. By 9pm I have a low fever of 100 and extreme muscle aches. feeling fevery and with very sore muscles.   I had symptomatic (though not hospitalized) COVID several months ago and recovered with no lingering symptoms.
Very fatigue, tiredness, light- headache, muscle soreness around injection site for the whole day after receiving 2nd dose Moderna vaccine.
Administration of expired moderna vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administration of expired moderna vaccine) in a 56-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administration of expired moderna vaccine). On 11-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administration of expired moderna vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment medications were reported.  No treatment given on the patients.
On the evening of February 25, 2021, the injection site began to itch intensely and a rash developed. From that evening through today, March 1, 2021, the itching has diminished though it does still itch somewhat. The rash continues, expanding out from the injection site. I have experienced no pain nor fever associated with the rash.
Myalgia severe localized myalgia with resultant bicep tendinitis 8 days after injection Narrative:  employee developed worsening pain in upper arm, worse with movement. has h/o prior arthritis and bursitis/tendinitis in that shoulder.
Information has been received from a physician concerning a female patient who on an unspecified date was vaccinated with a first dose of GARDASIL (Lot# unknown). The physician reported that immediately after injection, the patient looked like she was going to faint. Patient was in physician's office at that time she was observed and then released from physician's office. The physician indicated that she did not administer the 2 remaining doses of GARDASIL to her patient and she also indicated that the patient also states that she did not want to receive the 2 remaining doses of GARDASIL. At the time of the report, the patient had recovered (date unknown). It was unknown if the patient sought medical attention. Follow up information has been received from the physician concerning the 14 year old female student patient with no illness at the time of vaccination and no known pre-existing allergies, birth defects or medical conditions, who on 21-JUL-2010 at 11:00 am was vaccinated intramuscularly into the right deltoid with the first dose of GARDASIL (Lot # 666163/0664Z). On the same day, the patient was vaccinated intramuscularly into the left deltoid a dose of VAQTA (Lot # 667869/0560Z) and intramuscularly into the left deltoid with a dose of MENACTRA (Lot #U3080AA). The physician stated that after receiving the vaccines, that patient stepped off the table and sat on a chair, about 30 seconds after, the patient was found with her head turned to right and upwards, cyanotic stiff, eyes dilated and unresponsive. The patient was moved to the table and laid down. The physician stated that the patient awoke approximately 30 to 60 second after she was placed on the supine. No post-ictal phase. The patient stated that it was weird and had no memory of the event. The physician thought that it was a vasovagal episode with pseudoseizures/dystonic component. On 21-JUL-2010, the patient had recovered. No further information is available.