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 PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Feb-2021 at 8:37 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 17-Feb-2021 at 8:37 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced 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, PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (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.   Age of patient was reported as 70.24 No concomitant medications were reported. On 17-Feb-2021 at 08:00 A.M., the temperature recorded was 20 degree , Total doses given for the day was 62 and vial was initially moved to the fridge on 09-Feb-2021 and beyond use date was 10-Mar-2021. Product moved to clinic on 17-Feb-2021.   Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour. No treatment medications were reported.   This case was linked to MOD-2022-566976 (Patient Link).
Pruritus; This case was reported by a physician via call center representative and described the occurrence of pruritus in a 6-month-old female patient who received Rota (Rotarix lyophilized formulation) (batch number 2534R, expiry date 30th November 2020) for prophylaxis.   On an unknown date, the patient received the 1st dose of Rotarix lyophilized formulation (oral). On an unknown date, less than 9 months after receiving Rotarix lyophilized formulation, the patient experienced pruritus. On an unknown date, the outcome of the pruritus was unknown.   It was unknown if the reporter considered the pruritus to be related to Rotarix lyophilized formulation.  Additional details were provided as follows: The age at vaccination was not provided. The patient experienced pruritus after receiving first dose of Rotarix. The reporter consented to follow-up.
This spontaneous report was received from a registered pharmacist concerning a female patient who on an unknown date was vaccinated with a dose of ZOSTAVAX (dose, route and lot # not provided). On an unknown date, the patient developed shingles. It was reported that the patient sought medical attention, she went to the pharmacy on 28-AUG-2012. At the time of the report, the patent had not recovered from the event. The relatedness for the event was unknown for ZOSTAVAX. Additional information is not expected.
This case was reported by a healthcare professional and described the occurrence of arm and shoulder discomfort in a 29-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). Concurrent medications included prenatal vitamins. On 3 February 2010 at 10:15 the subject received 1st dose of BOOSTRIX (.5 ml, unknown route, right arm). On 3 February 2010, less than one day after vaccination with BOOSTRIX, the subject experienced arm discomfort, shoulder discomfort and decreased ranges of motion. The subject was referred to an orthopedic/physical medicine healthcare professional to evaluate for brachial neuritis and possible rehabilitation. The healthcare professional considered the events were disabling and clinically significant (or requiring intervention). The subject was treated with unknown (OTC products) without effect. At the time of reporting the events of arm discomfort, shoulder discomfort and decreased range of motion were unresolved. The healthcare professional considered the events of arm discomfort, shoulder discomfort and decreased range of motion were probably related to vaccination with BOOSTRIX.
10 minutes post-vaccine - tingling in both arms, all the way down arms. Right arm subsided after 20 minutes, but left arm continued to be warm and tingly. Left leg and foot tingly. 2 hours post-vaccine - Left side of face warm and tingly. Left back muscles heavy and fatigued, 24 hours later subsided. 12/21/20 - Left forearm to pinky tingling, palm numb. Left side of face pink and heavy.
red marks; itchy; feels hot and warm; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (red marks), PRURITUS (itchy) and FEELING HOT (feels hot and warm) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     Concomitant products included METFORMIN, NIFEDIPINE, LISINOPRIL, LOVASTATIN, CARBIDOPA, CLOPIDOGREL and CALCIUM, COLECALCIFEROL (CALCIUM VIT D) for an unknown indication, CYANOCOBALAMIN (VITAMIN B 12 [CYANOCOBALAMIN]) and VITAMIN D3.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, the patient experienced ERYTHEMA (red marks), PRURITUS (itchy) and FEELING HOT (feels hot and warm). At the time of the report, ERYTHEMA (red marks), PRURITUS (itchy) and FEELING HOT (feels hot and warm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details not provided.
pt went to ER feeling allergic rxn;diff breathing & swelling 23OCT97;tx pred;
Information has been received from a physician concerning a female patient with unspecified psychiatric problems and restless legs syndrome who in December 2007 was vaccinated with a dose of GARDASIL vaccine (Lot not reported). Recently the patient was diagnosed with peripheral neuropathy. The patient sought medical attention at the office. As of 13-JAN-2009 the outcome of the patient was unknown. Additional information has been requested.
Subcutaneous tissue of left arm; Pain at injection site (left arm); This spontaneous case was reported by a consumer and describes the occurrence of INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Subcutaneous tissue of left arm) and VACCINATION SITE PAIN (Pain at injection site (left arm)) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 07M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous) 1 dosage form. On 16-Feb-2021, the patient experienced INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Subcutaneous tissue of left arm) and VACCINATION SITE PAIN (Pain at injection site (left arm)). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of one dose. On 16-Feb-2021, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Subcutaneous tissue of left arm) had resolved. On 19-Feb-2021, VACCINATION SITE PAIN (Pain at injection site (left arm)) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous) was unknown.       No concomitant medication were provided   This case was linked to MOD-2021-047696 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 29-Jul-2021: Follow up received on 29-Jul-2021 contain non-significant information
Went to bed with racing heart and chills on the 23rd of March.  Felt weak on the 24th and couldn't go to work.  On the 27th, took my Lyme antibiotic, Tinidazole.  Felt weak on the 28th.  Better on the 29th and took second antibiotic - Azithromycin - in the AM.  Early that evening, began feeling burning skin, pins & needles in arms and upper body, severe chills with no fever, frequent urination and bowel movements, chest wall pain and high anxiety.  Tried to go to bed, was unable to sleep because chills lasted throughout the night.  Went to hospital at 7AM on the 30th.  Was released same day.  They didn't prescribe anything.  Spent the next two weeks on bed rest due to severe weakness and fatigue.  Went back to work on Tuesday, 4/13/21, for four days.  On Saturday and Sunday was bedridden again.  Went into work on 4/19/21 and was sent home due to racing heart and weakness.  On Saturday, 4/24/21, went back into hospital with racing heart, chills, weakness, nausea, chest wall pain, high anxiety.  Release same day.    Didn't go to work from 4/26-4/30.  Took leave of absence from work (I am an elementary school teacher) from May 3-June 23, 2021.
This spontaneous report was received from a pharmacist referring to an unspecified patients of unknown age and gender. The patients' pertinent medical history, drug reactions and allergies were not reported. On an unknown date the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (lot # L044694, expiration date 04-FEB-2018 and M010671, expiration date 02-Jun-2018). Concentration, dose and route of administration were not provided. The patients' concomitant medications were not reported. No adverse effects were reported. Additional information has been requested.
i have received my 2nd dose of pfizer and in the evening i experienced chills, fever arm left side pain swelling and redness...following on the next day i woke up with subclavian lymph node swollen like a ball on my left side. I also experienced this on the 1 st shot. It was hard to deal with the effect of this i also have pain nerve pain and muscle ache all over my body.  treatment included tylenol outcome is not recovered. day 2.
Information was received from a pharmacist referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On an unknown date, the patient was administered improperly stored RECOMBIVAX HB (lot# M010671, expired date 02-JUN-2018, dose unknown) intramuscularly. The vaccine was exposed to multiple excursions totaling 10 hours and 55 minutes to a low temperature of 32 Fahrenheit degree (F). No adverse effect was reported. Additional information has been requested.
shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of an unknown age. The patient's concurrent conditions, medical history and concomitant medications were not reported.  On an unspecified date in 2016, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, dose #, lot #, expiration date and route of administration were not provided) for the long-term prevention of shingles and/or zoster related conditions by a physician in a physician's office. Subsequent to the patient's  inoculation, the patient was treated by the physician for shingles. As a direct and proximate result of the patient's use of zoster vaccine live (ZOSTAVAX) vaccine, patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future.  The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
were just ill the first one; made him sick for a day or so; Headache; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (were just ill the first one), ILLNESS (made him sick for a day or so) and HEADACHE (Headache) in an adult male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     Concurrent medical conditions included Multiple sclerosis. Concomitant products included VITAMIN D3, SERTRALINE and VITAMIN C [ASCORBIC ACID] for an unknown indication.   On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form and dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ILLNESS (were just ill the first one), ILLNESS (made him sick for a day or so) and HEADACHE (Headache). At the time of the report, ILLNESS (were just ill the first one), ILLNESS (made him sick for a day or so) and HEADACHE (Headache) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   It was reported that patient had received total of 3 moderna vaccines. and the patient had a different effects and were just ill with first one and felt good and it makes to sit down for 15-20 minutes. The second one had a headache before left the building, the third one were down for the day and each time it got felt worse and with 2nd and 3rd vaccinations made sick for a day or so. No treatment medications were reported.
On Dec 2 I started with a cough but as the days went on it got worse. At first, I thought it had something to do with the plants in my house thinking it was just allergies. On Monday dec 5 I started having stuffy nose. I got COVID-19 in the hospital when I was having gallbladder surgery.  On Dec 6 I tested at COVID-19, and it was negative. Then the next day when my allergy medication wasn't working, I tested for COVID-19 again and, I was positive. I then started having fever, body aches, coughing, and a little bit of the runny nose. I called the nurse line, and they connected me to the doctors dealing with COVID-19 patients, I was prescribed Paxlovid, and it helped with my fever and all the other symptoms. On Dec 13 I tested again and was negative then again on 15 which was negative and then once more on December17.
COVID 19 Treatment; COVID 19 Treatment; Pfizer, Date: 25Nov2022 / Moderna, Date: 10Sep2021; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from product quality group. The reporter is the patient.  A 45-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 25Nov2022 as dose 4 (booster), single (Lot number: 6J3R275) at the age of 45 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 27Jan2021 as dose 1, single (Lot number: 041L20A), in left arm, on 24Feb2021 as dose 2, single (Lot number: 011A21A), in left arm and on 10Sep2021 as dose 3 (booster), single (Lot number: 052E21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). Patient has no known allergies. The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 25Nov2022, outcome "unknown", described as "Pfizer, Date: 25Nov2022 / Moderna, Date: 10Sep2021"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 03Apr2023, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (03Apr2023) Positive; (07Apr2023) Negative; (12Apr2023) Positive, notes: Tested with at home COVID test and it was positive again. Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient received Paxlovid on 03Apr2023 within 24 hours of first symptoms and positive COVID test. Symptoms were nasal and sinus congestion, sore throat. Completed all doses and felt much better in day 3 of Paxlovid. Tested negative 07Apr2023. Then 12Apr2023 in the late afternoon started to feel sinus pain and nasal congestion. Symptoms continued to escalate rapidly to include body aches and sore throat. Tested with at home COVID test and it was positive again.; Sender's Comments: Based on available information, a lack of efficacy under interchange of vaccine products with the suspect vaccine BNT162B2, BNT162B2 OMI BA.4-5 in this patient cannot be completely excluded.
upper body hive like rash - both arms, back and chest - resolved in 24 hours. None itchy  I did have a lace like rash with the 2nd booster but only on upper arm.   no new exposures such as lotions, detergents, soaps or others that may have caused rash - no others in home had similar
approx 6hr p/vax pt exp itching;entire arm became swollen & erythematous;no SOB;pt recovered later & was rechecked on 5MAR98;swelling resolved on 75% of lt upper extremity;still some swelling, redness, heat
Pain in lungs; Palpitations; shortness of breath; This is a spontaneous report from a contactable consumer (patient reported for herself). A 42-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, lot number: EN6208), via an unspecified route of administration, administered in arm left on 31Mar2021 at 13:15 (01:15 PM) (at the age of 42-year-old) as dose 2, single for COVID-19 immunization. The patient medical history was reported as none. The patient concomitant medications were not reported. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EN6205), via an unspecified route of administration on 10Mar2021 (at the age of 42-year-old) as dose 1, single for COVID-19 immunization and experienced palpitations, shortness of breath. The patient past drug included Bactrim and experienced allergy. On an unspecified date in Mar2021, the patient experienced palpitations and shortness of breath. On 02May2021, the patient experienced pain in lungs. Adverse event resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Reported Event: I have been having palpitations and shortness of breath since I have been vaccinated. 02May2021, I started having pain in my lungs. I have been to cardiologist and primary care physician and so far, all test and blood work have been normal. More tests are scheduled. I had no symptoms or issues until after I received the COVID 19 vaccination. The patient underwent lab tests and procedures which included test and blood work have been normal on an unspecified date in May2021. It was unknown whether the patient was received treatment. The outcome of all the events was not recovered at the time of the report. Device date was 03May2021.  No follow-up attempts were needed. No further information was expected.
got his Covid 19 vaccine including the booster/but anyway he had got infected with covid, as well as his 16 years old daughter and a 45 years old female.; got his Covid 19 vaccine including the booster/but anyway he had got infected with covid, as well as his 16 years old daughter and a 45 years old female.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 45 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine ("Primary Immunization series complete; unknown manufacturer"), for COVID-19 Immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "got his Covid 19 vaccine including the booster/but anyway he had got infected with covid, as well as his 16 years old daughter and a 45 years old female." Clinical course: The Reporter reached to provide his feedback regarding Pfizer Covid-19 Vaccine. Considered himself a vaccine believer, got his Covid 19 vaccine including the booster and followed all the indications like the use of masks, but anyway he had got infected with Covid, as well as his 16 years old daughter and a 45 years old female. Not to know the virus variant that infected him. Reported Chest issues derived his infection and also reported that many people around were also infected. In comparison with the Flu Vaccine, there should be a new Covid vaccine every year, but it's not the case.  The lot number for bnt162b2 was not provided and will be requested during follow up.
During being observed patient stated to medic that her  heart was beating fast and is having body flashes.  Patient taken to medic station.  EKG and vital signs were done which showed within normal range.  Patient observed and released in 30 minutes.
heaviness in my face; chills; light headedness; don't feel like myself; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 55-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: not reported, expiry date: not reported, Age at vaccination: 55-year-old) via an unspecified route of administration on 07Apr2021 as DOSE 2, single for COVID-19 immunisation. Medical history and concomitant medications were not reported. Historical vaccine included BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EN6198, expiry date: not reported, Age at vaccination: 55-year-old) via an unspecified route of administration in arm left on 17Mar2021 04:00 PM as DOSE 1, single for COVID-19 immunisation. On an unspecified date, patient experienced heaviness in my face, occasional chills, light headedness and don't feel like myself. Facility type Vaccine was Workplace clinic. No other vaccine received in four weeks. No other vaccine received in two weeks. Patient had not covid prior vaccination. Patient was not covid tested post vaccination. No known allergies present. Lab test included PCR test: negative (nasal swab) on 25Mar2021. The outcome of events was unknown.  No follow up attempts are possible; Information about lot/batch number cannot be requested. No further information is expected.
I have not had a period since August of 2020, I received the vaccine on Monday, May 3 2021 and began menstruating on 5/4. It began as a light flow, but has been heavy since around lunch time on 5/4.
pt recvd vax & after leaving ofc 10-15 min p/ vax pt began screaming; screaming cont except for brief naps til mom called on 15oct ;pt taken to ER where they confirmed vax rxn ; knot noted on LL;