chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Dose administered after more than 1 temperature excursions during a period of 33 weeks on 2021; Dose administered after more than 1 temperature excursions 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 (Dose administered after more than 1 temperature excursions during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Dose administered after more than 1 temperature excursions during a period of 33 weeks on 2021) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-2021 at 10:05 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 12-Feb-2021 at 10:05 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Dose administered after more than 1 temperature excursions during a period of 33 weeks on 2021). In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Dose administered after more than 1 temperature excursions during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Dose administered after more than 1 temperature excursions during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Dose administered after more than 1 temperature excursions 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.   Patient age was reported as 43.14.  No concomitant medication was reported by reporter.   It was reported that patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F.    Vial was punctured right before administration.   No treatment medication was reported by reporter.   This case was linked to MOD-2022-566976 (Patient Link).
Pt was triaged to the clinic complaining of chest tightness and pain, headache, shakiness.  Heartrate was strong but irregular.  Pt has no history of heart issues in his charting while incarcerated.  No provider on site, but oncall privider was called for  orders.  Patient observed for several hours in clinic.  Ate 100% of his dinner, encouraged to drink more fluids as original BP 98/44.  May have been slightly dehydrated. Pt released from clinic at 7:00PM BP at that time was 96/60 pt still had about a 4/10 headache, but was steady on his feet when returning to his housing unit. Seen by nursing on 2/12/23 BP 109/66 Pt states no new symptoms.  Pt. seen by APRN on 2/13/23 Patient stated he felt better, not sure if it  could have possibly been issues with seizures, he has only been having seizures for about 6 months, so it was unclear if  the issues was seizures, dehydration, the vaccine or possibly a combiation.  No orders at that time, pt was told to follow up if he had any more issues.  Pt. has had some shakiness since the encounter but no chest pain or tightness.  He has  requested  his second vaccine.  Pt has been advised that due to not  knowing if this was a true adverse reaction it would be best to not get the second dose at this time.
pt states approximately 24 hours after the vaccination he noticed, numbness and tingling of his left arm and a heaviness in his chest. symptoms have improved over the past week. He did not seek medical attention when the symptoms first started.
This spontaneous report as received from an approximately 72 years old male patient concerning himself. Patient had drug reactions/ allergies to penicillin. On 15-OCT-2014, the patient was vaccinated with PNEUMOVAX 23 lot # K005797, expiry date 21-MAR-2015, injection. Concomitant therapy was aspirin. On 15-OCT-2014, patient developed swelling, soreness, and redness at the injection site, as well as: nausea, fever of 101, stomach pain, constipation for a day and half, and flu like symptom after receiving PNEUMOVAX 23. Patient did not seek medical attention. On an unknown date in October 2014, the outcome of events was resolved. Causality was not reported. No product quality complaint (PQC) was involved. No additional information provided. Additional information has been requested.
No AE; PROQUAD temperature excursion; This spontaneous report was received from a medical assistant referring to a 4 years old patient of unknown gender. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications was provided.  On 23-JUL-2021, the patient was vaccinated with improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA)(PROQUAD) lot # T030944, expiration date 09-MAR-2022 (dose number, dose and route of administration were not reported) for prophylaxis.  The vaccine was stored improperly in the temperature between 14 degrees Fahrenheit (F) and 46 degrees Fahrenheit (26.6 F) for the time frame of 3 hours and 20 minutes. There was no previous temperature excursion. Digital Data Logger was not involved. No adverse event was reported.  ; Sender's Comments:  US-009507513-2107USA008378: US-009507513-2107USA008671:
Received MMR and DTaP on 11/12/04. This morning, noticed whelping rash first in diaper area, then spreading to arms, legs and lower trunk. Denies fever. No unusual foods, no medications given. Referred to pediatrician. Follow up: Received Benadryl and more blood testing done on 12/6/04. 11/18/04 Mom states patient has recovered.
Morning nausea; Mild pain at injection site 48 and 72 hours later; This is a spontaneous report from a non-contactable consumer, the patient. A 51-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0198) via an unspecified route of administration in the left arm on 14Jul2021 at 19:45 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19 since prior to the vaccination, the patient was diagnosed with COVID-19 on an unknown date. The patient did not have any allergies to medications, food, or other products. Concomitant medications included levothyroxine sodium (SYNTHROID) 100 mcg and amitriptyline hydrochloride (ELAVIL) 25 mg. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 16Jul2021 at 04:00, 48 hours after vaccination, the patient experienced mild pain at injection site. On 17Jul2021, 72 hours after vaccination, the patient experienced morning nausea. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. The clinical outcome of the events mild pain at injection site and nausea was resolving at the time of this report.   No follow-up attempts are possible. No further information is expected.
Patient was purchasing merchandise at the front end of the store, when he fell over and apparently hit his head. The employee ringing out his items notified pharmacy personnel to assess the situation. The pharmacist on duty, asked a series of questions to assess if patient fell over due to the receiving the vaccine. Patient did not directly answer the question but identified that a situation like this has previously happened once before (unknown time frame). Patient was seated in a chair, looked pale, identified that he had a drink of water after collapsing, identified that he had not had anything to eat prior to coming to the pharmacy. Pharmacist instructed patient to hang out for another 10-15 minutes for observation, but he got up and left shortly after the conversation ended.
face red. patient denied any other issues. redness increased and darkened while assessing. patient directed to go to ER. daughter driving.
Pt is a 61 yr/o female who presents to the ED for further evaluation of paresthesia.  Patient states that 2 days ago she started having intermittent numbness and tingling to her hands and legs.  She reports that the numbness and tingling seems to be worse in the mornings.  She denies numbness and tingling at present time.  Patient is also complaining of dry mouth and urinary frequency.  She called her primary care physician with her complaints and she was advised to come to the emergency department for concerns of increased blood glucose.  Patient reports fever today in the emergency department and weakness. 12/13/21  She denies chills, chest pain, shortness of breath, cough, abdominal pain, nausea, vomiting, diarrhea, difficulty urinating, dysuria, loss of strength in extremities Patient reports that she has a history of chronic headaches and that she has a headache to the left side of her forehead which is similar to the headaches in the past.  Patient states that she had experienced paresthesias to her bilateral arms 2 years ago and received a nerve conductions test at that time which yielded normal results
33y.o. G6P2032 at 39w2d by L=8w5d who presents with cc of passing blood clots since her membrane sweep. SVD 8/17 baby. Pt satisfied from care measures provided.  Vss, ambulating and voiding without difficulty, fundus firm, scant lochia, tolerating regular diet, declining pain meds. Prescriptions given. Discharge instructions discussed/signed and all questions answered. Mom in walking out for discharge.
patient expired dose of Imovax was administered, no AE; Initial information received on 30-Dec-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves patient of an unknown demographics who received an expired vaccine RABIES (HDC) VACCINE [IMOVAX RABIES] (lot N1L132M and expiry date: not reported) via unknown route in unknown administration site, on an unknown date.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was a case of actual medication error due to expired vaccine used. It was reported that to the patient an expired dose of Imovax was administered.  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.
I had the commonly reported reaction a day later - fever, chills, headache, fatigue, arm pain.  Severe enough to miss work, the only day I missed at that job in 15 months.  However, even when it calmed down the next day, I continued to have chills and intense headaches daily.  Over the following 2-3 months, more of my Hashimoto's symptoms flared up in addition to the chills and headaches -- sudden weight loss, fatigue, hair loss, constipation, dry flaky skin, excessive sense of cold even on hot days in summer, splitting nails.  Now in December 2021, the headaches and chills have calmed somewhat and are less severe but still present, and all other symptoms are ongoing.  I had 3 PCR covid tests in late May 2021 and all were negative. I have not been to see a doctor about this yet because I'm new to the area and don't have a specialist yet locally.  I'm very reluctant to have the covid booster, as I fear it will worsen the Hashimoto's symptoms that are finally improving after over 7 months of dealing with the reaction the last time.
Headache, Myalgia, Fever, CoughWheeze & Diarrhea Narrative:  Took acetominophen. Symptoms improving past 24 hours.
Aches, pains, stomach pains, and diarrhea, dehydration.
Whiney but not ill at bedtime. Mom checked and found him choking face down in crib, had thrown up clear major drool. Was breathing, but lump, lips blue, eyes glazed. To ER by ambulance. Temp 102F. Doctor diagnosed viral episode. Was in ER 1.5 hours then home. Low fever but acting normal next day. Has bad cold cough and runny nose now. Fever reducer given in ER.
Sore shoulder; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization, reaction(s): "sore shoulder for a day or two"; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunization, reaction(s): "sore shoulder for a day or two"; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), for COVID-19 immunization, reaction(s): "sore shoulder for a day or two". The following information was reported: ARTHRALGIA (non-serious), outcome "recovered", described as "Sore shoulder".  Additional information: The patient had all Pizer vaccinations and boosters except the one for the Omicron booster which was Moderna. The patient had never had a reaction to any of them except a sore shoulder for a day or two.  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-PV202200129597 same patient/vaccine/event, different dose;
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 14-MAR-2017, the patient was inoculated with ZOSTAVAX at a pharmacy as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On an unspecified date, the patient was treated by a physician for a blistering vesicular outbreak that was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX, and/or despite receiving ZOSTAVAX for the long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
8/12/22 pt brought to Hospital for generalized weakness, dyspnea, hypotension; found to be positive for COVID; UTI, AKI, sepsis, pneumonia, hypoxic respiratory failure; O2 supplementation; dc'd to hospice care; bed confined; unable to meet needs; pt passed away in the hospice facility
nausea; hasn't been feeling well since; high heart rate; This is a spontaneous report from a contactable consumer (patient herself) via Medical Information Team. A 61-year-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration on 14Jul2021 as dose 1, single (at the age of 61-years-old) for COVID-19 immunization. Patient medical history included allergies. The concomitant medications were not reported. Patient had the first dose of the Pfizer BioNTech COVID-19 vaccine last Wednesday (14Jul2021) and she had not been feeling well since. She went to ER last Sunday because of nausea and high heart rate but her heart rate came down on its own. She mentioned they gave her hydration and anti-nausea medications via IV. She was still not feeling good, she still felt unwell. She wanted to know if these have been reported common side effects with the vaccine since the ER said nothing was wrong with her. She was worried about getting the second dose of the Pfizer BioNTech COVID-19 vaccine because of her experience. They did not give her anything for her heart rate, but it came down. They did give her IV hydration and anti-nausea medicine. She still did not feel good though. She goes to the doctor tomorrow. She feels like slush. She had allergies, but she did not experience anaphylaxis. She was concerned why she is feeling so unwell. On an unspecified date in 2021, the outcome of the event heart rate increased was resolved, of the event feeling unwell was unknown while that of the event nausea was not recovered.   Information on Lot/Batch number has been requested.
No additional AE reported; Nurse reported two temperature excursions on multiple refrigerated vaccines.  There was a prior excursion on 5/3/2022 and a recent excursion on 5/26/2022.  She said it was very likely all vaccines had been administered since the excursions occurred.; This spontaneous report has been received from a nurse, concerning a 06-months-old female patient. No information was provided regarding the patient's pertinent medical history, concomitant medications, concurrent conditions, and previous drug reactions or allergies.  On 03-MAY-2022, the rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot #U026664 experienced a temperature excursion of 47.3 Fahrenheit degrees (F) for 5 minutes, if a digital data logger was involved was not reported (product storage error).   Consequently, on 23-MAY-2022, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot number reported as U026664 confirmed as valid, expiration date reported and stablished as 24-FEB-2023) administered orally as prophylaxis (formulation, strength, dose, vaccination scheme were not provided) (product storage error). No additional adverse events (AE) reported (no adverse event).   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2206USA001582: US-009507513-2206USA001583: US-009507513-2206USA001584: US-009507513-2206USA001585: US-009507513-2206USA001586: US-009507513-2206USA001587: US-009507513-2206USA001588: US-009507513-2206USA001589: US-009507513-2206USA001590: US-009507513-2206USA001591: US-009507513-2206USA001592: US-009507513-2206USA001593: US-009507513-2206USA001594: US-009507513-2206USA001595: US-009507513-2206USA001596: US-009507513-2206USA001597: US-009507513-2206USA001598: US-009507513-2206USA001599: US-009507513-2206USA001600: US-009507513-2204USA001865: US-009507513-2204USA001998: US-009507513-2204USA002052: US-009507513-2204USA001952: US-009507513-2206USA001103:
2 hours post vaccine: chills, felt flush/hot face 12 hours post vaccine: swelling at redness at injection site 30 hours post vaccine: chills, body aches, headaches, fever, nausea 3 days post vaccine: redness, firm swelling and tender arm with itchy rash at and surrounding injection site
This spontaneous report as received from a nurse via a company representative refers to a 6 years old female patient. The patient's concurrent conditions, medical history and concomitant medications were not reported. In approximately 2012, reported as 4 years ago, the patient was vaccinated with a first dose of VARIVAX, subcutaneously (strength, site of administration, lot # and expiry date were not reported) and she did not experience any adverse effects after that vaccination. On an unknown date, the patient received second dose of VARIVAX, subcutaneously (strength, site of administration, lot # and expiry date were not reported). On an unspecified date, reported as 2 years after receiving the second dose of VARIVAX, she broke out in chickenpox. The outcome of the event was reported as recovered. The relatedness between the event and VARIVAX was not provided. Additional information is not expected, as there was no consent given to contact healthcare professional.
Severe swelling of arm around vaccination site.  Most of arm became very swollen, warm, painful.  Effects going on four days.
I feel like I am in menopause again; difficulty getting back to sleep; hot flashes; night sweats; wake up during the night; This is a spontaneous report from a non-contactable consumer, the patient. A 61-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 28Apr2021 at 12:00 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. Medical history included known allergies to sulfa and latex. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included aciclovir (ACYCLOVIR), magnesium glycinate (MANUFACTURER UNKNOWN), ascorbic acid (VITAMIN C), vitamin d nos (VITAMIN D) and multi (MANUFACTURER UNKNOWN);all from an unknown date for an unknown indication and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 07Apr2021 at 13:30 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. On 02May2021 at 18:30 the patient reported that she feels like she was in menopause again. she woke up during the night or early in the morning and had difficulty getting back to sleep, she was also having hot flashes and night sweats. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events she feels like she was in menopause again, she woke up during the night or early in the morning and had difficulty getting back to sleep, she was also having hot flashes and night sweat were not resolved at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
No adverse effects were reported.; A HCP called and reported an AE where an improperly stored dose of VARIVAX was administered to a patient.; This spontaneous report has been received from a medical assistant referring a 12-month-old patient of unknown gender. The patient's medical history, concurrent conditions, and concomitant medications were not provided.  On 22-JUN-2023, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) subcutaneous injection (lot number W039292 was determined to be a valid lot number, expiry date 11-DEC-2024) (strength, dose, frequency, and administration route were not provided) (Product storage error ) concomitantly with a sterile diluent (strength, dose, frequency, administration route, indication, lot number, and expiry date were not provided) both indicated as prophylaxis.  The varicella virus vaccine live (Oka/Merck) (VARIVAX) vaccine was stored at a temperature of 31.8 F (Fahrenheit) for a time frame of 11 hours and 43 minutes. There was no previous temperature excursion.  No additional adverse events were reported.
symptoms onset date 10/7/2021, Increase shortness of breath with rest and activity, cough, and chest discomfort.