chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Product temperature exersion; Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature exersion) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020F21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature exersion) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature exersion) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   there are no treatment or concomitant medications provided.
An expired Covid-19 pfizer vaccine was administered to the patient on 4/25/22.  The vaccine expired on 4/18/22 at 10am.  The error was discovered on 4/29/22. On 5/3, a COVID-19 Vaccine temperature related enquiry form was filled out and emailed to Pfizer.  On 5-9-22 at 7:51am, we received an email from Pfizer's quality team stating they do not have stability data to support our excursion from prescribed storage conditions. We have reached out to our affected patients informing them of the situation and offered to revaccinate them if they choose to. Left messages on 5-9,5-10, and 5-11 for patient to call the pharmacy back.
Irregular period- bleeding in between periods that started about 2 months after the second Moderna dose continuing for about 3 months
Severe whole body myalagia and weakness with inability to stand or walk without significant pain and weakness. Unable to work or do ADL . Doctors not sure what to do . Have seen pcp and ER with still severe pain and weakness over three days
This spontaneous report received from a patient concerned a 32 year old of unspecified sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose, start therapy date were not reported for prophylactic vaccination. 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 experienced shortness of breath / difficulty in breathing, difficulty in bowel function, difficulty with bladder control, chest pain, dizziness, muscle aches, headache, nausea, and weakness. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from shortness of breath / difficulty in breathing, difficulty in bowel function, chest pain, muscle aches, headache, dizziness, nausea, weakness, and difficulty with bladder control. This report was non-serious. Sender's Comments: V0: Medical Assessment Comment not required as per standard procedure as case assessed as non-serious.
Vaccines given and approximately 10 min. later mother noted small red mark on abdomen and side. Watched in office additional 20 min, child doing well, sent home with instructions to call if any further spots noted.
mistakenly gave 0.5ml instead of 0.3ml-(no adverse s/s at this time)-
9/1 pt claims when she got up the next day - below where she got flu shot - red, swelling, raised warm to touch - and puffy muscle - no fever no headache no pain. On 9/3 she came into see me and said swelling had come down - it was still red and warm to touch.
Fever with chills (temperature varied from 101-102 and would decrease to 99-100); This is a spontaneous report from a contactable healthcare professional (patient). A 39-year-old female patient (non-pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL3246), via an unspecified route of administration in right arm, on 08Jan2021 at 17:00, at a single dose, for COVID-19 immunization. The patient's medical history included hypertension, glaucoma, Wolff-Parkinson-White syndrome (treated with ablation previously), and COVID-19 (prior vaccination). The patient's concomitant medications included amlodipine, metoprolol, colecalciferol (VIT D3), ascorbic acid (VIT C), and vitamin B complex (VITAMIN B).  The patient previously took azithromycin (ZITHROMAX) and experienced allergies. No other vaccine was administered in four weeks. The facility where the vaccine was administered was a hospital. On 09Jan2021 (approximately 6 to 8 hours after the vaccine), the patient began running a fever with chills. The patient's temperature varied from 101-102 and would decrease to 99-100 with acetaminophen. The patient has not been tested for COVID-19 post-vaccination. The patient recovered from the event in Jan2021.
First dose of Moderna was March 4, 2021.  8 Days later developed COVID Arm in Left arm. Second dose of Moderna was April 1, 2021.  2 Days later developed COVID Arm in right arm. Also flu like symptoms that I did not experience with first dose.
Patient noticed a rash around neck and under chin 2 hours after receiving vaccine to treat she applied topical hydrocortisone and took fexofenadine.
The day after receiving her 2nd SHINGRIX vaccination, the patient had soreness around the injection site, redness, and the area felt hot. The symptoms were still present after 4 days. The red area was approximately 2-3 inches wide and 5-6 inches long. She went to an urgent care clinic and was told by the doctor that it was most likely a skin reaction to the vaccine and a hematoma. He did prescribe sulfamethoxazole/trimethoprim DS to take BID for 5 days to prevent/treat cellulitis.
Patient was exclusively breastfed and had regular stools throughout the day. After receiving vaccine she did not have a bowel movement without a suppository until March 2 2012. She became irritable and seemed to have abdominal discomfort and extreme discomfort with constipation. Patient took Miralax till she was 1 year old. Patient developed milk protein allergy. Was placed on Nutramigen AA Lipil and continues to have constipation issues now at 22 months old.
Left arm became red, swollen & hot after vaccination. No fever. Patient saw her physician & was told it was an allergic reaction to the vaccine. Treated with cortisone cream.
Didn't get second dose, can I still get it; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Didn't get second dose, can I still get it) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Didn't get second dose, can I still get it). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Didn't get second dose, can I still get it) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   Concomitant medication was not provided.  Treatment information was not provided.
Extreme dizziness 12 hours after the shot that lasted about 18 hours. Dizziness caused nausea and headache. I just haven't seen dizziness listed as a common side effect, only as a "severe" side effect. I need to know if I'll be worse after the second shot. Should I be concerned about having the second dose?
Report A0355897A describes an injection site reaction in a 4 year old male who received diphtheria and tetanus toxoids and acellular pertussis vaccine absorbed. Medical history, concurrent conditions, and concurrent medications were not specified. There was no illness at the time of immunization. The vaccinee had no adverse experiences following receipt of prior immunizations. On 27 NOV 2001, the vaccinee received an injection of Infanrix (lot DTPA522A2); it was not known if he had received previous injections of Infanrix. He also received an injection of varicella virus vaccine. on 28 NOV 2001, one day post immunization, he experienced an injection site reaction characterized by a 10 cm arean of redness and swelling, at the site of Infanrix administration. Severe induration was present in the center of this area. The reporter stated that it looks like cellulitis. The events resolved on 01 DEC 2001. The physician indicated that the injection site induration was severe in intensity, disabling/incapacitating, and related to Infanrix administration.
Severe chest pain at 2am , rapid heart beat and flutters. Couldn't go back to sleep had to take Tylenol just to calm the pain down
The caller said that 1 patient received Rotateq and Vaxelis after a temperature excursion; This non-serious spontaneous safety report with reference number 02082971 and 02082963 was received by a partner on 04-JAN-2022 and forwarded to regulatory authority on 07-JAN-2022 from a health care professional.  The causal relationship between Vaxelis and the reported event of a patient received Rotateq and Vaxelis after a temperature excursion was assessed as not applicable due to the nature of the event.  Further information is expected.  SIGNIFICANT follow-up information was received by Fax from a HCP on 24-Jan-2021. The case is maintained as non-serious. The reporter confirmed that the patient did not experience any Adverse Event following the administration of Vaxelis.  The temperature excursion occurred because a vaccine box did not allow the refrigerator to be closed completely. The vaccine box was moved and the door was closed completely.  No further information is expected.
This case was reported by a pharmacist via call center representative and described the occurrence of liver function test abnormal in a 76-year-old female patient who received SHINGRIX (batch number 455KD, expiry date 4th May 2021) for prophylaxis. On 4th February 2019, the patient received the 1st dose of SHINGRIX. On 11th February 2019, 7 days after receiving SHINGRIX, the patient experienced liver function test abnormal. On an unknown date, the outcome of the liver function test abnormal was unknown. It was unknown if the reporter considered the liver function test abnormal to be related to SHINGRIX. Additional details were provided as follows: The patient received dose of SHINGRIX on left deltoid and one week after experienced weird liver function test values. The patient previously has had normal liver lab values. Lab Comments: Previously, the patient had normal liver lab values. One week after receiving her dose of SHINGRIX, the patient had weird liver function test values.
Site: Pain at Injection Site-Mild, Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Exhaustion / Lethargy-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Hypertension-Mild, Systemic: Shakiness-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: 8 minutes after pt received Moderna vaccine, pt's mother yelled for help because the pt had passed out for a duration of 5-10 seconds then woke up. Pt was administered 1 dose of adult epipen and 911 was called. Once EMT arrived they took him to the hospital to be evaluated. He appeared to recover by demonstrating the ability to stand up walk around and respond to questions asked by the EMT.
Information has been received from a physician concerning a 32 year old male with asthma, ULTRACET and tramadol allergy who on 19-NOV-2006 was vaccinated with Pneumovax 23 (lot #651437/0899f), 0.5 ml, once, IM. Concomitant therapy included montelukast sodium (MSD), albuterol and FLONASE. On 21-NOV-2006, the patient developed pain, redness, warmth and 15 cm swelling at injection site two days after receiving Pneumovax 23. On 21-NOV-2006, the patient sought medical attention, was examined and was prescribed ice compress and non-steroidal anti-inflammatory drugs (NSAIDs). On 22-NOV-2006, the patient reported taking chills but did not check his temperature. On 27-NOV-2006, the patient was re-examined which revealed improvement of swelling but the redness continued. Additional information has been requested.
Swelling welt that is very hot.  The welt continued to swell overnight - the next morning it was approx 6" in diameter and still spreading and extremely hot.
Information has been received from a licensed visiting nurse concerning a patient who on 10-FEB-2010, "yesterday", was vaccinated with a dose of PNEUMOVAX 23 (Lot # not reported). On 10-FEB-2010, "right after getting the vaccine" the patient experienced fever and significant swelling of the arm. The patient was administered an epinephrine shot and recovered. The nurse also stated that she will hold off on administering the PNEUMOVAX 23 with that lot number to the patients. Follow up information has been received from the licensed visiting nurse who indicated that the patient was vaccinated with PNEUMOVAX 23 (Lot # 665300/1314Y). The licensed visiting nurse thought that the patient had been treated with SOLUMEDROL and an antibiotic (unspecified). The licensed visiting nurse did not consider the patient's fever or swelling of the arm to be life-threatening. The licensed visiting nurse stated that according to the office's policy they were not administering PNEUMOVAX 23 with the lot # 665300/1314Y. The nurse also reported that the patient had not received an epinephrine shot, as previously reported. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the center for Biologics Evaluation and Research and was released. This is one of two reports received from the same source. Additional information has been requested.
Approximately 5 minutes after injection, pt began complaining of shortness of breath and her throat closing up.  She was brought back to the exam room and had audible stridor.  Racemic epi was administered via nebulizer and she also received 4mg decadron IM.  Afterward her stridor had resolved and she had no more distress.  Due to a significant reaction in her sister, she was transported via ambulance to Emergency Department.  She was admitted for observation and po benadryl to the floor.  Early this am in the hospital she developed stridor and shortness of breath again and has required IV decadron.  She will remain in the hospital until she is stridor free for 24 hours.  8/14/09 Hospital admitting record DOS 8/12/09. Assessment: Anaphylactic reaction to pneumococcal vaccine 27 valent. Transported to ER bay ambulance. Past vaccination patient grabbed throat and felt that she could not breath. Significant stridor on auscultation. Throat dry. Throat and chest red rash. Administered racemic epinephrine by nebulizer. Decadron IM.  ICD-9 Codes: Allergic reaction 995.3, Anaphylaxis 995.0  8/19/09 PCP medical records DOS 8/12/09 to 8/18/09. Assessment: Respiratory distress, stridor, adverse reaction to Pneumovax. Resolved respiratory distress. Follow-up visit. No cough, wheezing, chest pain, shortness of breath, no feeling of throat closing up.  8/19/09 Hospital discharge summary DOS 8/12/09 to 8/14/09. Assessment: Anaphylactic reaction to Pneumovax. After stabilization patient was transported and admitted to hospital. Later developed developed shortness of breath immediately relieved by IV Decadron. Some scattered wheezes on auscultation. Faint expiratory wheeze.
A few days after the vaccine was given the patient developed disturbance in his smell.  He now states that everything smells "rotten".
This is a spontaneous report from a contactable pharmacist, based on the information received by Pfizer from Merck (Merck# 00573110). A 77-year-old male patient of unspecified ethnicity received PREVNAR 13, via an unspecified route of administration, in Jan2017, at single dose, for immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced hives on an unspecified date. Hives were resolved but came back about 6 weeks later and at repeated cycles, going away and coming back a few times. Outcome was unknown. No follow-up attempts possible. No further information expected.
Hep B vaccine initially given on 06/27/18, second Hep B vaccine given on 6/29/18. No adverse reactions noted.
cold sore right outside her mouth; This spontaneous case was reported by a consumer and describes the occurrence of ORAL HERPES in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Thyroid disorder.   On 03-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, the patient experienced ORAL HERPES. At the time of the report, ORAL HERPES outcome was unknown.            Patient's concomitant medication included unspecified medicine for thyroid.  Treatment medications was not provided by the reporter
she woke up with 3 fingers on her rights side that felt like pins and needles with numbness in them.; she woke up with 3 fingers on her rights side that felt like pins and needles with numbness in them.; her right thumb "was off" feeling numb and with pain; This is a spontaneous report from a contactable consumer (patient reported herself). A female patient of an unspecified age received first dose of BNT162B2 (Pfizer-BioNTech Covid-19 Vaccine, Solution for injection) via an unspecified route of administration in her left arm on 26Mar2021 as single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. On 27Mar2021, the patient experienced woke up with 3 fingers on her rights side that felt like pins and needles with numbness in them and right thumb "was off" feeling numb and with pain. Caller reported that "she received her first Covid shot on Friday, March 26th in her left arm and on Saturday she woke up with 3 fingers on her rights side that felt like pins and needles with numbness in them. Caller reported that she went to her chiropractor for an adjustment, and it appeared to feel a little better, but she reported that her right thumb "was off" feeling numb and with pain. She reported that she missed her second dose because her son tested positive for Covid and so she got her second dose, again in her left arm, this Monday, April 26th. Caller reports that she was fine but then on Tuesday her right arm started feeling heavy with sharp pains in it and today she reported that her right thumb was "killing" and her right arm has a tingling sensation and numbness to it. She asked, is that normal or a side effect being reported from the vaccine". Confirmed Pfizer Covid vaccine. Spoke from attached documentation. Referred to HCP for evaluation and guidance. Caller reported that she already spoke with safety - reference r9mvdoqc. Survey offered. Therapeutic measures were taken in response to the events. Outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
On or about day 10, COVID arm appeared as well as the appearance of a wart on the inside of my R foot near the ankle. (At age 5, I?d had a plantar wart removed from the bottom of the same foot.) I know that I was not in an environment to pick up anything as I live with my elderly father and am meticulous about what I do and where I go. It began with the same type of insistent itching as COVID arm.   COVID arm disappeared around day day 17 post 1st injection. I am still dealing with the remnants of the wart. The wart has been treated with Cantharidin first followed by Imiquimod cream, which I am still currently using. So far, it has been nearly 3 mos of treatment.
10 minutes after the injection while I was sitting and relaxing, I felt my feet tingling with a pins and needles sensation. They also felt cold. The pins and needles and coldness then shifted to my hands as well.  It also happened in my lips and nose. I occasionally felt a cold tight feeling in my chest. I felt a little weak and shaky, like maybe I would faint but I did not. This did not improve with eating some candy and drinking water. I later felt anxious but the anxiety was brought on by these symptoms, as I was definitely not feeling anxious prior to the tingling. I tried resting and that did not resolve it. It just eventually stopped after about 6 hours.
pt recvd 2 doses of Hep B vax dialysis formulation 1ml instead of Hep B vax 1ml on 03OCT90 & 03NOV90. P/ 2nd dose,pt devel h/a & fever blisters thought to be infection w/ herpes simplex.
Three days after vaccination, patient's arm (site) became red, streaked & had small blisters. Bandaid was left on x 3 days. Doctor diagnosed "staph infection" and prescribed BACTROBAN 2% 3eGM & Sulfameth-trimeth susp on 2/4/10.
Patient received their Flu shot at facility, after sitting for a few minutes the whole Family walked to the elevator to go down to the car. While in the elevator the patient said he couldn't see and was feeling like his legs were going to give out. His parents held on to him and brought him back up to the Flu Shot Spot. The patient was conscious and able to answer questions, but the patient was quickly losing coloring and complaining he couldn't feel his hands and feet. When I arrived, the patient was able to tell my his name where he was and he could move all his limbs. His coloring was not good. He was laying down on the floor with his feet elevated on a chair. After drinking 3 juices and continued blow by the patient's color and vitals had returned to normal. F/U call at 11/21/18 at 1625 but no answer, RN.
Patient's mom called 7/12/02. Child received Hepatitis A 7/11/02. 15 minutes after shot, child developed rash on left arm. Hepatitis A was given in left arm. Mom called ER was told to give Benadryl. She did and rash went away.
24-48 hours, post vax, pt developed 100 typical varicella spots. No known exposure. Fever went to 102F with no secondary causes.
Guest patient, reported feeling dizzy, complained of being very weak after receiving her first dose of Pfizer Vaccine - (Lot #ER8712), administered in the LD at 14:37 hours. Guest complained of feeling ? ?the loss of strength?, to the upper part of her body and that she ?just wanted to close her eyes and sleep.? EMS activated to the Observation Area. Vital Signs assessed: B/P-110/60, P-74 (reg), R-18, T-98.5, 100%, and blood glucose reading of 94. EMS completed further evaluation and guest was released at 14:53 hours reporting that she was no longer experiencing the above complaints/or symptoms. She was offered and accepted water and more observation time. Client reported ?I am back to normal.? Client observed sitting talking on a cellphone and appears to be no apparent distress.
Fever, treated with ibuprofen 400 mg evry 4-6 hours, fever resolved in 24 hours Acid Reflux/Heartburn, treated with sodium bicarbonate, still ongoing 4 days after vaccine
Information has been received from a medical assistant on 02-JUL-2015, concerning a patient of an unknown age and gender. On 10-APR-2015, the patient was vaccinated with a dose of RECOMBIVAX HB 0.5 ml, lot # K010535, (expiration date, route and site of administration were not reported) that underwent 72 hours temperature excursion outside of the recommended range. No adverse effects had been observed or reported. This is one of several reports from the same reporter. Additional informatino has been requested.