chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 019B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Feb-2021 at 4:02 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 28-Mar-2021 at 4:04 PM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On an unknown date, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 24.65 years.  Concomitant products were not provided.  On 24-Feb-2021, the vaccine with batch number 014M20A was moved to fridge. On 27-Feb-2021, 20 vials were moved to the clinic. On 27-Feb-2021 vials underwent temperature excursion with temperature of 33, 34 and 35 degrees Fahrenheit from 09:00 AM to 01:00 PM. The condition of vaccine prior to vaccination was not frozen. The vaccine beyond use date was reported as 26-Mar-2021.  It was reported that, the storage condition at the time of the excursion was cooler storage during high-pace COVID-19 vaccination clinic. The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic. Temperature recordings were taken using a traceable temperature monitor at every hour.  It was reported that, the patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021. The health care professional explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree Fahrenheit.  Treatment medications were not reported.   This case was linked to MOD-2022-566976 (Patient Link).
terrible sore throat; A spontaneous report was received from a consumer concerning a 86-year old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced terrible sore throat.  The patient's medical history is not provided by the reporter, Concomitant medications reported include Aspirin 81mg, Metformin, Amlodipine, Vitamin B12, Imodium as needed, Metoprolol and Lisinopril for unknown indications.  On 14-JAN-2021  got the first dose of the vaccine on her right arm at Hospital, for the prophylaxis of COVID-19 infection. Patient has been fine until 17-Jan-2021 she got a terrible sore throat.   Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the event is Unknown.
In the evening my arm started to hurt. Overnight I started to feel flu like symptoms. The next morning most of the symptoms went away. I was tired for 3 days then everything went back to normal.
Sore arm at injection site, continuing through next day. Low grade fever/chills about 12 hours after injection. Significant dizziness, lightheadedness, headache and short fainting episode about 16 hours after injection, then mild headache and body ache throughout the rest of the day.
she felt so tired; her breathing was heavy and felt tight; This is a spontaneous report from a contactable nurse. A 67-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Batch/lot number: EL9262), at age 67 years, injection into the left upper arm/deltoid, first dose on 27Jan2021 14:00 at single dose, for COVID-19 vaccination. Ongoing medical history included diabetes diagnosed more than 10 years ago and high cholesterol diagnosed around 10 years ago, maybe longer. The patient's concomitant medications were unspecified maintenance medications because she is diabetic and has high cholesterol. She said that she has been taking these medications for a long time though already. Patient was a retired registered nurse that was calling about the COVID-19 vaccine and reported that she had the first dose injection on 27Jan2021 at 14:00 and 2 hours after she got home, she felt so tired that she did not feel like moving and her breathing was heavy and felt tight. Patient said that her breathing feeling heavy and tight did not last too long, maybe an hour then went away. Her tiredness, felt so tired lasted through the day and whole night and she was fine and completely recovered after waking up in the morning. For breathing feeling heavy and tight: She clarified that it lasted from like 14:00-17:00 yesterday 27Jan2021. Patient wanted to know with the symptoms she had is it contraindicated to get the second dose? She was reading the information about the injection and seemed like the symptoms are part of it. The outcome of the events was recovered, for felt so tired was on 28Jan2021 and for breathing was heavy and felt tight was on 27Jan2021. Case was reported as serious with other medically important condition as seriousness criteria. The reporter assessed the events she felt so tired and her breathing was heavy and felt tight as related to the suspect drug COVID-19 Vaccine.   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 currently available, a possible contributory role of the suspect drug in the reported events cannot be completely excluded given the known suspect drug profile and/or implied temporal association. 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 Regul atory Authorities, Ethics Committees and Investigators, as appropriate.
itching at the site; PENUMOVAX 23 was mistakenly given intradermally; PENUMOVAX 23 was mistakenly given instead of tuberculin PPD; This spontaneous report was received from a registered nurse concernign a 37-year-old non-pregnant female patient. The patient had no drug reactions or allergies. The patient's medical history, concurrent conditions, and concomitant medications were not reported.     On 03-NOV-2020 in the morning, the patient mistakenly received  pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (lot # S009238, expiration date: 11-FEB-2021, 0.1 milliliter, intradermal, indication reported as vaccination) instead of tuberculin purified protein derivative(PPD). On the same date in the evening, the patient was contacted and she was complaining of itching at the site (injection site pruritus). The nurse stated the patient woudl come into trhe office on 05-NOV-2020 to get her PPD read (was placed in opposite arm after error) and they would recheck the patient's arm for any further issues.  At the time of reporting, the outcome of injection site pruritus was unknown.  The causality assessment between injection site pruritus and pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) was not provided.
pt recvd vax; shakiness, trembling, hot flashes, rapid heartbeat, "room spinning", n, no v; happened on & off until 7pm; arm very sore; hard; swollen; hot to touch; 11jan94 tired, limited range  of motion Lt arm x 5 days, knot at site;
started w/high pitch cry was unconsolable lt thigh was swollen-went to ER given Motrin & Atarax
soreness in arm; Muscle aches; headache; Chills; Fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (soreness in arm), MYALGIA (Muscle aches), HEADACHE (headache), CHILLS (Chills) and PYREXIA (Fever) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029K20A and 039K20A) for COVID-19 vaccination.     No medical history information was reported.  Concomitant products included MIRABEGRON (MYRBETRIQ) for an unknown indication.   On 20-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Jan-2021, the patient experienced PAIN IN EXTREMITY (soreness in arm), MYALGIA (Muscle aches), HEADACHE (headache), CHILLS (Chills) and PYREXIA (Fever). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (soreness in arm), MYALGIA (Muscle aches), HEADACHE (headache), CHILLS (Chills) and PYREXIA (Fever) outcome was unknown.            Most recent FOLLOW-UP information incorporated above includes: On 16-Apr-2021: Nonsignificant Followup appended
Tested positive for COVID on April 29, 2022; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for COVID on April 29, 2022) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017f21a, 012m20a and 011a21a) for COVID-19 vaccination.     Concurrent medical conditions included Shellfish allergy. Concomitant products included VITAMIN D [VITAMIN D NOS] for Vitamin D supplementation.   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Apr-2022, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (Tested positive for COVID on April 29, 2022). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 29-Apr-2022 to 04-May-2022 for COVID-19, at a dose of 1 dosage form. At the time of the report, COVID-19 (Tested positive for COVID on April 29, 2022) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Apr-2022, SARS-CoV-2 test: positive (Positive) Positive. On 10-May-2022, SARS-CoV-2 test: positive (Positive) Positive (Rapid was immediately positive).         It was reported that patient felt better by the following day, and the symptoms again started on 08-May-2022.  Company Comment:  This is a spontaneous case concerning a 40-year-old female patient with no relevant medical history reported, who experienced the unexpected non-serious adverse event of special interest COVID-19 supported by a positive SARS-CoV-2 test, which occurred 6 months and 8 days after receiving the third dose of mRNA-1273 vaccine. Patient also received 2 doses of mRNA-1273 vaccine with 28 days interval, approximately 7 months prior to the third dose. Patient immediately started taking Paxlovid for 6 days and patient felt better by the following day. However, symptoms started again 4 days post-treatment of Paxlovid and patient was again tested positive for COVID-19. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 40-year-old female patient with no relevant medical history reported, who experienced the unexpected non-serious adverse event of special interest COVID-19 supported by a positive SARS-CoV-2 test, which occurred 6 months and 8 days after receiving the third dose of mRNA-1273 vaccine. Patient also received 2 doses of mRNA-1273 vaccine with 28 days interval, approximately 7 months prior to the third dose. Patient immediately started taking Paxlovid for 6 days and patient felt better by the following day. However, symptoms started again 4 days post-treatment of Paxlovid and patient was again tested positive for COVID-19. The benefit-risk relationship of mRNA-1273 is not affected by this report.
The patient is a 38 year old male who recently had a flu shot on 2/1/01, two days later on 2/3/01 he developed weakness of both lower legs from hips to legs. He reported to the ER on 2/4/01 where he was assessed as having back pain from muscle strain and was sent home on Naproxin. He returned on 2/6/01 with progression of weakness of both lower extremities and stiffness of both shoulders, digressed vocal tone, slurred speech and worsening of generalized proximal muscle weakness. ER physician discussed with neurologist at hospital and MD suspected of Guillain Barre Syndrome, was advised to start the patient on immunoglobulin at 400 mg per kg per day. On 2/6, the patient received only 12 grams of immunoglobulin. On 2/7, he had 28 grams of immunoglobulin. When I saw him on 2/7, he felt 60% improvement of the lower extremities weakness and improvement in the speech. He had no respiratory difficulty, no palpitation. The patient stated that he had a mild URI with fever and chills about one week before the flu shot. PAST MEDICAL HISTORY: Fracture of right ankle in 4/00, symptoms of heart burn suspected of gastroesophageal reflux disease, history of bunionectomy in 1986 both sides, history of superficial isolation of the abdominal wall during childhood. FAMILY HISTORY: Mother deceased at age of 42 of CA uterus and rectum. Father deceased at age 27 with melanoma, strong family history of diabetes mellitus and stroke. The patient does not smoke, does not drink alcohol. He works at a plastic company. PHYSICAL EXAMINATION: Vital signs are stable. The patient was conscious, alert, oriented, cranial nerves intact. He complained of weakness of both legs but on the physical examination, he was ambulatory, no weakness noted, deep tendon reflexes normal, Babinski negative. Lungs are clear. Heart with regular sinus rhythm, no peripheral edema. On 2/8, the patient's symptoms recovered completely 100%. He ambulated around ICU and speech was clear. Discussed with neurology and felt that the patient can be discharged. ASSESSMENT: Diagnoses as mentioned above.
Dizziness; Was having problems with the legs; Legs got really weak; Sore on the arm; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), LIMB DISCOMFORT (Was having problems with the legs), MUSCULAR WEAKNESS (Legs got really weak) and VACCINATION SITE PAIN (Sore on the arm) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, the patient experienced DIZZINESS (Dizziness), LIMB DISCOMFORT (Was having problems with the legs), MUSCULAR WEAKNESS (Legs got really weak) and VACCINATION SITE PAIN (Sore on the arm). In April 2021, DIZZINESS (Dizziness) and VACCINATION SITE PAIN (Sore on the arm) had resolved. At the time of the report, LIMB DISCOMFORT (Was having problems with the legs) and MUSCULAR WEAKNESS (Legs got really weak) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medications were reported. No treatment medications were reported.  Patient had dizziness and sore on the arm with the first dose but not too bad, it went away after 2 days. Patient noticed that legs had got really weak. Patient could walk but was having problems with the legs.   This case was linked to MOD-2021-393296 (Patient Link).
Rebound infection; Rebound infection; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 55-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Oct2022 at 14:15 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 55 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 08Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 15Apr2021 as dose 2, single (Batch/Lot number: unknown), in left arm, on 15Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 01Aug2022 at 11:30 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Multiple Sclerosis" (unspecified if ongoing); "Asperger's syndrome" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Macrobid, reaction(s): "Drug allergy"; Demerol, reaction(s): "Drug allergy". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Rebound infection". Therapeutic measures were taken as a result of vaccination failure, covid-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
The patient reported shortness of breath, coughing, malaise, body aches and fever. The injection site was warm and red. Symptoms occurred roughly 4 or 5 hours after the administration. Symptoms still present about 18 hours later but had markedly improved.
I got the shot, I got shingles/suspected vaccination failure; shingles; This case was reported by a consumer via  interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 1 year after receiving 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.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. A year after the patient got the shot, he/she got shingles and that was worst than giving birth. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory confirmation were unknown at the time of reporting. No contact details were available.
35 y/o female trying to conceive (able to test for positive pregnancy test in 2 days) received Fluzone High-Dose (IIV4-HD)
Pt screamed off & on several hrs; high pitched couldn't be consoled; no fever; leg swollen & red lt thigh;
This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 64-year-old male patient who received Herpes zoster (Shingrix) (batch number ZH327, expiry date 1st April 2023) for prophylaxis. On 20th October 2021, the patient received Shingrix. On 20th October 2021, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown. Additional details were reported as follows: The reporter reported that patient received the Shingrix which was reconstituted with saline, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow up.
Fever, chills, no appetite, very pink. Rash from shoulder to elbow. Very sore. Took TYLENOL.
Presented for Covid Booster shot. Patient requested Janssen Covid Vaccine. Technician administered Pfizer Pediatric vaccine in error. the vial was NOT reconstituted.  Dose drawn up was 0.5ml.  No side effects as of 2 hours after administration. Reporting error only.
Mottled skin which worsened with heat or precise crying, diagnosed 9/20/19 as Post-Inflammatory Hyperpigmentation   Development of ?silent? reflux
Per patient legs broke out in hives evening of injection 6/1/09.  Woke up next AM & hives on arms & legs.  Patient took 25 mg BENADRYL 8 AM on 06/02/09.  Instructed to take 50 mg @ 12:30.  On 6/3/09 mother was called & stated pt better went back to work
It went all the way into to her heart; It went all the way into her chest; felt like she was being stabbed through the spine; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 44-year-old female patient received BNT162b2 (BNT162B2), on 24Mar2021 as dose 2, single (Lot number: EP6955, Expiration Date: 30Jun2021) at the age of 43 years for COVID-19 immunization. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose 1, Lot no: EN6204, Expiration date: 30Jun2021), administration date: 04Mar2021, when the patient was 43-year-old, for COVID-19 immunization, reactions: "very cold like freezing", "very very tired", "severe pain that radiated from her spine to the right and left side", "It went all the way into her chest", "It went all the way into her heart". The following information was reported: ANGINA PECTORIS (medically significant), outcome "unknown", described as "It went all the way into to her heart"; CHEST PAIN (non-serious), outcome "unknown", described as "It went all the way into her chest"; SPINAL PAIN (non-serious), outcome "unknown", described as "felt like she was being stabbed through the spine". The patient underwent the following laboratory tests and procedures: Cardiac stress test: (01Jun2021) Unknown results; Chest X-ray: (unspecified date) Unknown results. She had reactions with the Covid vaccines and with each dose, it actually got worse. It was always with the arm. With the first one, she got very cold, like freezing and those symptoms lasted about 2 or 3 days. She was very very tired and had this very weird sensation. The doctor sent her for a chest Xray with the second one. With the first one, she had severe pain that radiated from her spine to the right and left side. It went all the way into her chest, to her heart. She had severe pain. This all happened with all 3 vaccines. With the second one, she felt like she was being stabbed through the spine.  No follow-up attempts are possible. No further information is expected.
Right ear pain, tinnitus, head pressure tremors, paresthesias , numbness on right side of body from toes to hands.Abdomial pain, waves of constriction and swelling across diaphragm. periods of shortness of breath, unintended wt loss periodic blurred vision PCP visits 2/23/21, 6/21/21 and others rec short steroid course, Neurology, MD rec steroids and Gabapentin MD ENT Ophthalmologist
25JAN96 recvd vax;28JAN96 devel pain in a banded area lower back;29JAN96 had diffuse erythematous welts w/clustering,which inc over 2 days & began to blister;t100.6 & cold sx;
Eye puffiness underneath left lower eye lid (more on the upper left side) symptom started Saturday
Patient admitted to facility for shortness of breath and cough for several days. Patient stated that they have had flu-like symptoms for 2 weeks. Patient also stated to have malaise, congestion, and body aches.