chrisvoncsefalvay/vaers-outcomes huggingface dataset:
vaccine was exposed to 31 degrees Fahrenheit for a couple of days/ no AE; Initial information was received on 18-Nov-2021 regarding an unsolicited valid non-serious case from a Pharmacist via Global Media Information (under reference- 00864089) and transmitted to Sanofi on 18-Nov-2021.  This case is linked to cases 2021SA389706, 2021SA392839 and 2021SA392842(CLUSTER).  This case involves a 67-year-old male patient who received INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] that was exposed to 31 degrees Fahrenheit for a couple of days with no adverse event (product storage error).  The patient's medical history, past medical treatments, concomitant medications, vaccinations, and family history were not provided.   On 12-Nov-2021, the patient received 0.7 ml (total) dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [lot UJ764AC and expiry date 30-Jun-2022] via intramuscular route in left arm for prophylactic vaccination.  It was reported "Caller stated that co-worker called in to report the excursion on Monday. Caller wanted to know what would happen if patient took product after being exposed to temperatures 31Fahrenheit degrees. What to the product when exposed to low temperatures?"  It was case of an actual medication error due to product storage error temperature too low (latency was on same day).  At the time of report, 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 holder's compliance with the requirements set out in the 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.
On Friday he woke up with headache, dizziness and nausea, symptoms continued to get worse, Monday was the worse day with the nausea. Mom reported that he felt feverish however did not take a temp. No diarrhea was reported. 07/27/16- I did send over a prescription of ZOFRAN to help the nausea.
injection site redness; injection site swelling; This case was reported by a nurse via sales rep and described the occurrence of injection site erythema in a 75-year-old female patient who received Herpes zoster (Shingrix) (batch number T4952, expiry date unknown) for prophylaxis.   On 20th May 2019, the patient received the 1st dose of Shingrix .5 ml. In May 2019, less than a week after receiving Shingrix, the patient experienced injection site erythema and injection site swelling. On an unknown date, the outcome of the injection site erythema was recovering/resolving and the outcome of the injection site swelling was unknown.   It was unknown if the reporter considered the injection site erythema and injection site swelling to be related to Shingrix.  Additional details were provided as follows: The redness and swelling at injection site went from quarter size in diameter to deck of cards size. On 23rd May 2019, redness was improving. Nurse asked if the patient should receive second dose. The reporter consented to follow up.
After coming home from the vaccine, I had no issues for 6-8 hours. I then started feeling extremely weak tired and thirsty. I checked my temperature, and I was actually running a temperature. To me, it felt like I needed fluids. It felt like my body needed more fluids to process the vaccine. I started drinking a lot more. I was basically on a liquid diet, soups, fluids etc. After about 3 days, I was fine. I did develop a sinus infection after but that is normal for me. I have allergies so that is something I was going to deal with regardless of the vaccine. My asthma and allergies were also on peak for that time of year. Last week, I had a sore throat and honestly thought I had COVID. My doctor looked at me and said I had no symptoms of COVID at all. My throat was so swollen in the front. After tests were done, it all came back normal. My thyroid is still swollen, and I concerns me, but I am not sure what the reason for this is. I do not know if it is from the vaccine at all but nothing else has changed nor have I done anything different since. This is the only thing that concerns me.
Information has been received from a Certified Medical Assistant (CMA) referring to a patient of unknown age and gender. The patient's concurrent and historical conditions were not reported. On an unknown date the patient was vaccinated with one dose of improperly stored (at 33.26F for 27 hours) RECOMBIVAX HB (lot # L044707, expiration date 06-OCT-2018, strength, dose and route were unknown). There was no temperature excursion issues previously. Concomitant therapies were not reported. No adverse effects were reported. Additional information has been requested.
high grade fever >103 & maculopapular rash 8 days p/vax;
This spontaneous report as received from a pharmacist refers to a newborn female patient of unknown age. On 19-OCT-2012 02:12, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot # were involved and the lot # were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot # the patient was administered. The outcome of the event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Patient stated that her left arm became red, swollen and hurt at the injection site. She took TYLENOL for the pain. Patient stated that she had the vaccine on 10/3/11 and just remember to call me on 12/9/11.
Fever of 104.3° that doesn?t break-even with Tylenol. The lowest it goes is 101.5.  Every square inch of my body feels like it?s on fire. My joint pain is a 10 out of 10.  Also have an awful headache.
dull pain in my side; This case was reported by a consumer via interactive digital media and described the occurrence of pain dull in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. In December 2020, less than a week after receiving Shingrix, the patient experienced pain dull. On an unknown date, the outcome of the pain dull was unknown.   It was unknown if the reporter considered the pain dull to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The age group was captured as an adult as per vaccine indication. The patient stated that he/she had pain in side, was that a side effect of his/her Shingrix vaccination from 4 days before reporting.
Body ache, headache, loss of appetite, fever (99 degrees), nausea, vomiting, fatigue, minimal site pain. Similar to symptoms of diagnosed  Covid I had in late December 2020.  Symptoms disappeared by the following day (except for minor site pain).
Pain in left arm, shoulder, unable to move arm in any direction, weakness, numbness of hand and fingers, unable to grip.
This spontaneous report as received from a registered nurse refers to a female patient in her 20's. The patient was vaccinated intramuscularly with dose 1, 0.5 ml GARDASIL (lot# not reported) about 1 year ago, in approximately September 2011. No other co-suspects were reported. No concomitant medications were reported. The nurse reported that the patient experienced immediate redness and swelling of her entire arm within a few minutes of administration of her first dose of GARDASIL in approximately September 2011. The patient also experienced syncope in approximately September 2011. The patient sought medical attention in the office and received BENADRYL. No laboratory diagnostic studies were performed. Subsequently on an unknown date, the patient recovered. The relatedness for the event was unknown for GARDASIL. Additional information is not expected.
chills; body aches; This spontaneous case was reported by a consumer and describes the occurrence of   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.   On 26-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. The patient was treated with IBUPROFEN for Myalgia and Chills, at an unspecified dose and frequency.            Action taken with mRNA-1273 in response to the events was not applicable No concomitant and treatment medications were reported.
get a flu symptoms reaction every time; 3 days off home sick every time; Initial information regarding an unsolicited valid non-serious case received from a consumer (patient) via social media on 19-Oct-2020.  This case is linked to case 2020SA296404 (cluster).  This case involves a patient of unknown demographics who got a flu symptoms reaction (Influenza) and 3 days off home sick (Illness), while the patient received vaccine Influenza Vaccine.  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medication was unknown.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiration date were not reported) via unknown route in unknown administration site as prophylactic vaccination.  On an unknown date, the patient got a flu symptoms reaction every time (Influenza) and 3 days off home sick every time (Illness) (non serious) (latency-unknown) following administration of Influenza vaccine.  It was reported as the patient didn't want flu shot ever again.  No laboratory data was provided  It was not reported if the patient received a corrective treatment.  The event outcome was unknown, at the time of reporting.  There will be no information about the batch number in this case.
received 2nd dose of Moderna covid-19 vaccine one week after receiving 1st dose; sore arm; fever; body aches; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received 2nd dose of Moderna covid-19 vaccine one week after receiving 1st dose), PAIN IN EXTREMITY (sore arm), PYREXIA (fever) and MYALGIA (body aches) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003A21A and 044A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm), PYREXIA (fever) and MYALGIA (body aches). On 29-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received 2nd dose of Moderna covid-19 vaccine one week after receiving 1st dose). On 29-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received 2nd dose of Moderna covid-19 vaccine one week after receiving 1st dose) had resolved. On 16-Apr-2021, PAIN IN EXTREMITY (sore arm), PYREXIA (fever) and MYALGIA (body aches) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   no concomitant drugs included no treatment drugs included
Beginning in the evening 2/19/21, fever/chills/fatigue; worsening of symptoms 2/20/21 with lethargy/lack of appetite/weakness; unable to arouse on 2/21/21 then breathing stopped, patient's spouse called 911 performed CPR, EMS continued for 15 min then while in ambulance to hospital  where he was pronounced dead.  Official time of death 2:20pm
As per mother, child became very pale and sleepy, 2-3 hours after vaccinations were given. It lasted for 20-25 minutes. She took him to E.R. at hospital.
Pain at injection site, body aches, sweating, shivering, nausea. Pain at injection site started immediately. Rest of side effects started around 8pm and lasted around 24 hours. Nausea lasted 72 hours
blood clots on legs, arms/blood clots on fingers; palpitation racing heart; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult male patient received BNT162b2 (BNT162B2), in Apr2021 as dose 1, single (Batch/Lot number: unknown) and in May2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: THROMBOSIS (medically significant), outcome "not recovered", described as "blood clots on legs, arms/blood clots on fingers"; PALPITATIONS (non-serious), outcome "not recovered", described as "palpitation racing heart". The event "blood clots on legs, arms/blood clots on fingers" required physician office visit. The patient underwent the following laboratory tests and procedures: Palpitations: palpitation racing heart, notes: palpitation racing heart. Therapeutic measures were not taken as a result of thrombosis, palpitations.  Clinical course: Batch/lot was Unknown because Unable to locate or read the details. Facility where the most recent COVID-19 vaccine was administered was Pharmacy or Drug Store. The patient was not received any other vaccines within 4 weeks prior to the COVID vaccine. Reported Event was palpitation, racing heart, blood clots on legs, arms. Blood clots on fingers. These continue to appear every time he take NSAIDs even after one year of vaccine shots. The patient was not diagnosed with COVID-19 and since the vaccination, the patient was not tested for COVID-19. Device Date : 02May2022  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This case was reported by a nurse via call center representative and described the occurrence of fever in a 52-year-old male patient who received SHINGRIX (batch number 3Z4KL, expiry date January 2020). Concurrent medical conditions included shingles (experienced in 2014). On 2nd February 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 2nd February 2018, several hours after receiving SHINGRIX, the patient experienced fever, muscle pain, fatigue and lethargy. In February 2018, the outcome of the fever, muscle pain, fatigue and lethargy were recovered/resolved. The reporter considered the fever, muscle pain and fatigue to be almost certainly related to SHINGRIX. It was unknown if the reporter considered the lethargy to be related to SHINGRIX. Additional details were provided as follows: The health care professional reported no concomitant vaccine administration and no significant medication or medical history. The reported batch number of SHINGRIX CZ4KL did not exist and was updated to 3Z4KL as per sales data sheet. The patient received SHINGRIX in the left deltoid. The patient experienced a fever (99.8 degrees Fahrenheit), muscle aches and fatigue. Less than a week after receiving SHINGRIX, the patient experienced lethargy. About 4 pm, the patient experienced fatigue within on the day of vaccine administration. Fever was noted a few hours later, before he went to bed. The patient contacted the office by phone and TYLENOL was recommended. The symptoms were resolved after about 2.5 days.
1 week later large swelling at injection site  and swelling of ipsilateral auxiliary lymph node
ear infection; This is a spontaneous report from a non-contactable consumer (the patient) via a Pfizer sponsored program, . This female patient of an unspecified age received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on 11Mar2021 as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced ear infection and was prescribed with amoxicillin (an antibiotic treatment). She was also wondering if she can take Colace or a stool softener today (13Mar2021). The clinical outcome of the ear infection was unknown.  No follow-up attempts are possible; information about batch/lot number cannot be obtained.
Neurological vocal and motor tics; Neurological vocal and motor tics; This is a spontaneous report from a contactable consumer. A 21-year-old female patient received first dose of BNT162B2 (BNT162B2) via an unspecified route of administration, administered in Arm Left on 01Mar2021 16:00 (Batch/Lot Number: EN6200) as SINGLE DOSE for covid-19 immunisation. Medical history included ehlers-danlos syndrome from an unknown date. The patient previously took codeine, metoclopramide, prochlorperazine, vancomycin and experienced allergies. The patient experienced neurological vocal and motor tics on 02Mar2021 seriousness criteria was reported as disability and medically significant. Therapeutic measures were taken as a result of neurological vocal and motor tics. Outcome of the events was not recovered.
sharp, shooting pain in the tips of her fingers; shooting pain in the tips of her fingers, joints and back; shooting pain in the tips of her fingers, joints and back; pains woke her from her sleep; This is a spontaneous report from a contactable consumer. This report was received via a sales representative. A 35-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot/batch number and expiration date not provided), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), at single dose for COVID-19 immunization. Patient experienced sharp, shooting pain in the tips of her fingers, joints and back. The symptoms started 10 hours after administration of the 2nd dose of the bnt162b2 on an unspecified date, and lasted for 12 hours. The pains woke her from her sleep. Event took place after use of product. The outcome of the events was recovered on unspecified dates.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Starting Monday, 4.19.21 evening I started taking ibuprofen 800mg. I continued this Tuesday due to arm ache, taking 800mg at 0600, 1400, 2000. I started having a headache mid afternoon. I also  took Tylenol 500mg and Benadryl 50mg at 2000 Tuesday eve due to arm pain. At  2200 I woke with uncontrollable chills and  fever of 100.8, nausea and vomiting.  At 2300 I was able to take 1000mg  of Tylenol and the chills went away at midnight.
Patient received first dose of Moderna vaccine on 5/4/21 and received second dose on 7/19/21 (77 days), which is over the recommended amount of time between doses (24-42 days).
Rash all over my legs, back, thighs, the upper legs and my arms; This is a spontaneous report from a contactable consumer or other non hcp. A 56-years-old female patient received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EN6206), dose 1 via an unspecified route of administration on 10Mar2021 as DOSE 1, SINGLE for covid-19 immunisation. Medical history included blood cholesterol from an unknown date and unknown if ongoing Verbatim: Cholesterol. The patient's concomitant medications were not reported. Nurse practitioner said to take Benadryl (treatment) which patient did and said it makes you sleepy. She worked part time. So she took it for 3 days Tuesday, Wednesday Thursday and Friday and then she went to take something different. She had to take the weekend off. So the initial Saturday and got a week and a half. Nurse practitioner told patient that you are going to take the vaccine on 31st start taking Claritin. She started taking Claritin last week for 7 days because she was going to get that tomorrow. The patient experienced rash all over my legs, back, thighs, the upper legs and my arms on 14Mar2021. The outcome of the events was recovered. Therapeutic measures were taken as a result of rash all over my legs, back, thighs, the upper legs and my arms (as patient said she was taking Claritin to avoid reaction) No follow-up attempts are needed. No further information is expected.
Monday the 26th I developed a runny nose which continued most of the afternoon and evening, I had tested for COVID-19 and was negative. When I went to bed it stopped. When I woke up on the 27th I had a very dry throat and had some difficulty talking. I got up and drank some water and it got a little better. We were traveling that day and I didn't feel too bad during the day, we got back during the evening and I tested again and was positive. I called my PCP after hours and spoke with an assistant and they offered an antiviral but declined due to the size of the pills.  I had a headache, and a low grade fever, and took some Tylenol. Wednesday I woke up and did not feel all that bad, took a few Tylenol throughout the day. Yesterday, Thursday, the runny nose came back and some coughing, but disappears at night. My current temperature is 98.4 which is slightly above normal, but overall just feel like I have a cold. My throat is still sore from the post nasal drip.
acute cerebrovascular accident/ Severe right sided weakness/dysarthria/double vision/Vomiting/nausea; This initial spontaneous report was received from a lawyer regarding a case in litigation, referring to a patient of unknown age and gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In or around 12-NOV-2015, the patient was inoculated with zoster vaccine live (ZOSTAVAX) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster) (strength, dose, route of administration, anatomical location, lot#, and expiration date were not reported). On an unknown date, reported as shortly after received zoster vaccine live (ZOSTAVAX), the patient suffered severe right sided weakness, dysarthria, double vision, nausea and vomiting. The patient was hospitalized and diagnosed with an acute cerebrovascular accident.  As a direct and proximate result of the patient's use of the zoster vaccine live (ZOSTAVAX) vaccine, the patient had resulted in physical limitations not presented prior to used zoster vaccine live (ZOSTAVAX). Also experienced mental and emotional distress due to resulted physical limitations and seriousness of her condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate resulted, the patient had suffered and incurred damages, included medical expenses, the loss of accumulations; and other economic and non-economic damages. The outcome of cerebrovascular accident, nausea, vomiting, diplopia, dysarthria and hemiparesis was not recovered. The reporter considered the aforementioned events to be related to Zoster Vaccine Live (ZOSTAVAX).  Upon internal review, cerebrovascular accident and hemiparesis were determined to be medically significant events.
expired Hep B given 1/27/04 expired 1/11/04.