chrisvoncsefalvay/vaers-outcomes huggingface dataset:
muscle ache/ muscles were tender to the touch; swollen arm/swollen at injection site; sore arm/sore at injection site.; This case was reported by a nurse via call center representative and described the occurrence of swelling arm in a adult 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, unknown after receiving Shingrix, the patient experienced swelling arm, pain in arm and muscle pain. On an unknown date, the outcome of the swelling arm, pain in arm and muscle pain were recovered/resolved.   It was unknown if the reporter considered the swelling arm, pain in arm and muscle pain to be related to Shingrix.  Additional details were provided as follows: The reporter was the patient,wanted to remain anonymous and refused to answer questions. The patient reported that, at the time of reporting to the clinic, they told her that they had other patients,had the same reaction. The patient stated that, she had sever swollen and sore injection site reaction and also had swollen and sore arm for a significant amount of time including the bicep and forearm for almost 2 months. It was a deep muscle ache lasting beyond 4 weeks which the muscles were tender to the touch and achy. Limited data were reported, as the patient did not want a report filed and wanted to get off phone. For tolerance to 2nd dose of Shingrix, refer case US2019AMR128561.  This case was linked with the master case US2019AMR128562, reported by the same reporter.
Sever left arm pain, neck pain, bilateral shoulder pain, right arm pain, headache, nausea
an improperly stored dose of PEDVAX was administered to the patient; No adverse effects.; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's concurrent conditions, medical history or concomitant medications was provided.  On an unknown date, the patient was vaccinated with an improperly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) lot # N024570 and expiration date: 01-MAY-2020 (exact dose, frequency and route of administration were not reported) for prophylaxis. No adverse effects were reported.  The vaccine was stored in the temperature below 36 Fahrenheit (F) in 32.1 F for 8 hours. There was no previous temperature excursion. The improper storage was recorded because of digital "data logger".
devel redness in eyes & a sl rash, temp, sz, jerking, stared w/temp of 103, irritable, rash, red eyes persist;
angioedema, urticaria, petechiae (allergy) apothous ulcers of mouth & tongue;episodes of hot flashes & hyperpnea tx w/long acting antihistamine, oral urticaria lasted 5mo to NOV97;
Fever of 102 degrees, chills, headache, body aches - admitted at ER and blood cultures, urine cultures and analysis and other labs were performed. Also a CT of the brain and lumbar puncture were done. Everything came back negative.
nausea & diarrhea 4MAY95; vomiting 4MAY95; ache all over, stomach cramps 6MAY95 to present (9MAY95);
Pt recvd vax & 1 day later exp nausea, muscle aches & gastrointestinal sx;
oral bumps at times but not painful; occasional diarrhea; Chills; fever; body ache; This spontaneous case was reported by a health care professional and describes the occurrence of APHTHOUS ULCER (oral bumps at times but not painful), DIARRHOEA (occasional diarrhea), CHILLS (Chills), PYREXIA (fever) and MYALGIA (body ache) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product PALBOCICLIB (IBRANCE) for Breast cancer.    No Medical History information was reported.   In September 2020, the patient started PALBOCICLIB (IBRANCE) (Oral) 125 milligram once a day. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Apr-2021, the patient experienced CHILLS (Chills), PYREXIA (fever) and MYALGIA (body ache). On an unknown date, the patient experienced APHTHOUS ULCER (oral bumps at times but not painful) and DIARRHOEA (occasional diarrhea). In April 2021, CHILLS (Chills), PYREXIA (fever) and MYALGIA (body ache) had resolved. At the time of the report, APHTHOUS ULCER (oral bumps at times but not painful) and DIARRHOEA (occasional diarrhea) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Red blood cell count: lower red blood count but stable. On an unknown date, White blood cell count: lower white blood count but stable.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  On 28-Oct-2021, patient experienced another episode of chills, fever and body ache after the mRNA-1273 (Moderna COVID-19 Vaccine) for couple of days (resolved on an unknown date of Oct-2021).  Treatment information was not provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   Reporter did not allow further contact
Pt was fine during the shots, but when she stood up her legs were shaking and she was holding her ears and throat, she was pale and warm to touch, able to answer questions and state what was wrong with her; sent to ER, spoke with mom and ER both report child doing fine upon arrival to ER.
noadverse effect were reported; the patient was inadvertently administered one dose of expired ZOSTAVAX; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 22-JUL-2019, the patient was inadvertently vaccinated with one dose of expired zoster vaccine live (ZOSTAVAX) 1 dose, lot# R020227 has been verified to be a valid lot number, expiration date 29-JUN-2019 (exact dose, site, route of administration were not reported) for prophylaxis. No adverse effects were reported. The nurse verified that the product had not had any temperature excursions. The outcome of the event was unknown.
I woke up with a fever took a home COVID-19 test that came negative. I tested because my husband had tested positive and I thought I may also get it. I retested the next day and the home COVID-19 test then came back positive. I had a low-grade fever, aches, headache that lasted for six days. Then I started having a tightness in my chest, I called the doctor, he prescribed me a MEDROL dose pack. I am still feeling tired, but I am not using the inhaler as much.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old male patient received BNT162b2 (BNT162B2), on 29Oct2021 as dose 3 (booster), single (Lot number: fg3527) at the age of 53 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown). The patient's relevant medical history included: "Hypertension" (unspecified if ongoing). Concomitant medication(s) included: VITAMIN C [ASCORBIC ACID]; ZINC; LORATADINE; ATORVASTATIN CALCIUM, stop date: 19Apr2022; AMLODIPINE BENAZEPRIL. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (01May2022) Negative; (03May2022) Positive; (2022) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical Course: The patient received COVID 19 Treatment (Brand: Paxlovid), from 19Apr2022 to 24Apr2022. It was further reported that on friday 29Apr2022, the patient started to feel similar COVID symptoms returned (sore throat). He tested negative with an at home rapid test. The symptoms continued and I tested negative on 01May. on 03May I started with a cough and congestion. The patient tested positive with a rapid at home test.  No follow-up attempts are possible. No further information expected.
Fever, chills, nausea, vomiting, headache, muscle soreness, chest pain, increased respiratory rate, shortness of breath, cough, diarrhea, difficulty concentrating, fatigue
Fever, confusion, rash requiring hospitalization, IV antibiotics, spinal tap, labs, CT scan of head, MRI.
2 hours after shot (influenza given), patient complain of full body itching. No hives, no difficulty breathing.
Patient mother states she has no history of reaction to prior immunizations. Mother noticed a redness and swelling to child's left arm last night while giving her a bath on 01/05/05. On 1/06/05 mother brought patient into health department and patient's left shoulder area was warm, red swollen and had a raised area of about 4 inches in diameter. Mother was advised to seek medical attention from PCP. Since patient had no local PCP, her mother stated she would take her to the ED. Patient was given Benadryl on 01/05/05 by her mother, but she stated it had no effect.
Initial report was received from a healthcare professional on 04 September 2013. A female patient (age and date of birth not reported) had received an injection of FLUZONE (Sanofi Pasteur, lot number, route and site not reported) in 2012 and an unspecified amount of time later experienced arm pain. At the time of the report, the patient was still complaining of arm pain and underwent physical therapy. Outcome was not recovered. Documents held by sender: None.
Pt. received first Pfizer covid vaccine at 5:45pm. He was brought to the observation area for 30 minutes of observation due to hx of anaphylaxis to penicillin. At approximately 5:55pm, RNs noticed that Pt had his head in his hands. When questioned, he stated he didn?t feel well. He was helped to the ground and his legs were elevated. His vitals were 190/90, P 88, Resp 34. The nurses helped him to a sitting position as he was feeling better and he answered some medical history questions. He shared that he was Type I Diabetic. He stated he checked his blood sugar last yesterday. He ate breakfast today and took insulin. No food since this morning. Patient had no symptoms of anaphylaxis and no chest pain or other complaints. Patient denied SOB or ?throat tightening?. No hives. Patient became diaphoretic and stated he was overheated. RNs helped to remove his shirt. Observation RN alerted Nurse practitioner of the ongoing incident. Nurse Practitioner went to seek sugar sources, suspecting the patient was severely hypoglycemic. Patient, still conscious and responsive and sitting up, took 10 oz. orange juice and frosting was massaged by APRN, in buccal area with patient consent. Patient initially seemed to be improving per APRN and RNs caring for patient. BP was 170/90 at next check. P 80.  Regular respirations. Still no anaphylaxis symptoms (no hives, no angioedema, no throat tightening or wheezing). A few minutes later, Pt started shaking and said he was chilled. Patient was returned to supine position with legs elevated. He continued to shake and patient lips blue ? sweatshirt placed over him. RN noted that Pts? eyes rolled back in his head. RN went to alert the Clinical Team Manager/RN of the situation and stated that 911 should be called as patient not improving. Clinic Team Manager/RN concurred. While RNs stayed with patient and informed patient?s friend about what would occur, Clinic Site Manager  called 911. BP 140/80 at next check. Patient continued to sweat and have chills. Rescue squad arrived ? blood sugar was 116. After emergency services assessment of patient, emergency services checked blood sugar again and it had dropped to 88 within those ~5 minutes. Patient was taken by Emergency Services at 6:36pm. RN  noted that the patient remained with emergency services in parking lot  for several minutes and then pt was transported to the hospital by the emergency services. His wallet, glasses and hat were given to his friend who had accompanied patient to the vaccination clinic. His friend stated that she would call patient?s wife to inform her that patient was taken to ED by emergency services.
The next day, woke up, felt crappy, sore throat and headache. As the day wore on got dizzy, nauseous and vomited for 3-4 hours. I could not eat. Sunday had toast and ginger-ale and it stayed down, balance was off. On Sunday took Pepto-Bismol and Tylenol. Did not resolve symptoms. I stayed away from food until Monday. I felt much better on Monday. I was not dizzy and could eat a little. Tuesday felt much better. Holistic healer realigned immune system and patient felt normal again. Still sore and swollen arm.
Inability to focus, inability to think, taking longer to recall information, head feels like it's filled with cotton (Started around 10:20 on 03/11/2021, still persisting at the time of this being written, which is 21:12)
On 2/29/00 the pt broke out with a mild case of chicken pox, consisting of 10-15 lesions. It was noted that the pt was afebile. Unspecified medical attention was sought. Additional information has been requested.
Initial report received from a healthcare professional on 08 JUNE 2012. A 42-year-old female patient, who denies any illness at the time of vaccination and whole medical history and concomitant medications were not reported, received a dose of ADACEL (batch number: C4169AA, site not reported) intramuscularly on 13 JUNE 2012. It was not known at the time of vaccination that the patient is pregnant, as her urine pregnancy test was negative. Later on it was confirmed by the blood test that she was pregnant. On 18 JUNE 2012, the patient started spotting and was sent to ER. Corrective medications were not reported. As of 18 JUNE 2012, the outcome of the event was unknown.  List of documents held by sender: none.
patient received 2 doses of the Fluzone Quadrivalent prefilled syringe 10 minutes apart yesterday with no specific side effects or symptoms; Initial information regarding an unsolicited valid non-serious case received from a healthcare professional on 29-Dec-2020.  This case involves a 11-year-old male patient who received 2 doses of the INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] prefilled syringe 10 minutes apart yesterday with no specific side effects or symptoms (lot UT71151A, expiration date: 30-Jun-2021) for prophylactic vaccination (extra dose administered).  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication was unknown.  This was an actual medication error case due to the event extra dose administered (latency: on the same day). At the time of reporting, no adverse event was reported.  Disclaimer: this suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in directive 2001/83/ec and module VI of the good Pharmacovigilance practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available regarding batch number in this case.
cold hot, cold, hot; Sweats; dull headache; This case was reported by a consumer via media and described the occurrence of feeling hot and cold in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (1st dose received on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, less than a week after receiving Shingles vaccine, the patient experienced feeling hot and cold, sweating and headache dull. On an unknown date, the outcome of the feeling hot and cold, sweating and headache dull were unknown.   It was unknown if the reporter considered the feeling hot and cold, sweating and headache dull to be related to Shingles vaccine.  Additional details were provided as follows: The patient self reported the case. The age at vaccination was not reported. The patient stated that everyone would react differently to the shots. The patient had both shot of Shingles vaccine the first one not happen and 2nd shot, the patient reacted to acted as a 3 to 4 day bug. hot ,cold hot ,cold , sweats an a dull headache. this was within the last 4 days and was hoping never to have shingles. The follow up would not be possible as no contact details were available.
pt recv vax 1MAR96 & 12APR95 pt exp lymph node swelling & aches & pains in leg;a biopsy showed that the nodes were benign;pt lymph node swelling & ache & pains in leg persisted;no further details were provided;
This case was reported by a other health professional and described the occurrence of vaccine underdose in a 56-year-old female patient who received ENGERIX B (batch number AHBVC199AA, expiry date 5th February 2015). On an unknown date, the patient received ENGERIX B .5 ml. On an unknown date, an unknown time after receiving ENGERIX B, the patient experienced vaccine underdose. On an unknown date, the outcome of the vaccine underdose was unknown. It was unknown if the reporter considered the vaccine underdose to be related to ENGERIX B. Additional information received: Per HCP, MA at facility has been administering 0.5 ml dose of ENGERIX B to adult patient. One patient has been identified, HCP believes there are several other patients.
I had nausea, chills, and three days of terrible diarrhea, then 3 days of not so bad diarrhea. This lasted for about a week. About seven days later I was feeling sick again and tested positive for Rhinovirus. I had a sore throat for two days, congestion and a cough. I contacted my doctor, but no medication was prescribed. I did take SUDAFED, eucalyptus oil and garlic honey lemon tea.
10-24-07 Mom phoned stating that as soon as she left the health unit her child had fever.  10-19-07, 10-20-07, 10-21-07, 10-22-07, 10-23-07-states she never took his temperature because she does not have thermometer.  Child developed welps on torso and back of neck, saw PMD.  10-23-07-Dx of urticaria, Rx for Pediaped & Benadryl.  Mom states child did not miss any school.
Patient was here for a third dose booster. They previously received 2 doses of Pfizer. This third dose they accidentally received a  dose of Moderna. This error was noticed the next day. Our Medical Director called them on 9/7/21 to make sure that they were aware of what happened and to let them know that per the CDC they should be fine and should not repeat the dose. She reported: When I asked how he was today he responded "terrible."  He explained that he's had significant back pain.  He stated that he was advised to have surgery but he's heard bad things about that & is hesitant to do that.  He has an appt tomorrow for a shot at a pain clinic.  A pack with pills they gave prior helped only a little bit.  He also intends to see a chiropracter.  I extended my concern for his pain & encouraged him to keep his appt tomorrow with the pain clinic.  I then advised him of the reason for my call He had previously received 2 pfizer vaccines.  When he came in for the booster, he was given Moderna. Patient became very upset & began yelling & using profanity. He advised that since he & his brother had the shot that they've not felt right with headaches & arm soreness. "You messed us up." Was repeated several times He expressed concerns that we could have killed them.  I apologized for the error and assured him that we were reviewing what happened in order to make a corrective action plan to prevent it from happening again. He advised it was already too late as it happened to him & his brother.  I advised that per CDC guidance, it is not ideal to receive Moderna after receiving Pfizer, but it is possible & does not have to be re-boostered with Pfizer. Harm would also not be expected. He advised that he will be in contact with other groups for their opinion including his lawyer.  I advised that headache & arm soreness is typical after the immunizations - both Pfizer & Moderna - & that after several shots, the reactions may be intensified since the immune system is already primed to fight the disease.  He reiterated the above phrase with profanity.  He then asked if I had another else to say because he had several phone calls to make. I offered to answer any questions he may have & again apologized that the mistake happened.  He stated he did not have further questions & we would hear from his lawyer ...........
Symptoms began immediately. Right arm painful with a red, raised rash. Went to Allergist on 1/30/03.
Date the vial was initially stored was on 31 Jan 2022 and patient administered vaccine on 07 Apr 2022; Patient administered vaccine on 07 Apr 2022 and thaw expiration date was on 02 Mar 2022; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine on 07 Apr 2022 and thaw expiration date was on 02 Mar 2022) and PRODUCT STORAGE ERROR (Date the vial was initially stored was on 31 Jan 2022 and patient administered vaccine on 07 Apr 2022) in a 31-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 045L21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 07-Apr-2022 at 9:16 AM, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to .5 milliliter. On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 07-Apr-2022 at 9:16 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine on 07 Apr 2022 and thaw expiration date was on 02 Mar 2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Date the vial was initially stored was on 31 Jan 2022 and patient administered vaccine on 07 Apr 2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine on 07 Apr 2022 and thaw expiration date was on 02 Mar 2022) and PRODUCT STORAGE ERROR (Date the vial was initially stored was on 31 Jan 2022 and patient administered vaccine on 07 Apr 2022) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported.  It was reported that patient received doses after the beyond use date.Date vials were  initially stored in refrigerator was reported as  31 Jan 2022.  It was reported that the thaw expiration date was on 02 Mar 2022, and the total doses given were 20 doses of 15 vials used.  It was reported that the vials had not undergone any temperature excursion.  No treatment medication were reported.