chrisvoncsefalvay/vaers-outcomes huggingface dataset:
dose administered to patient after more than 1 temperature excursion; dose administered to patient after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (dose administered to patient after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019B21A and 014M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Feb-2021 at 3:36 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 27-Mar-2021 at 3:55 AM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 27-Mar-2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (dose administered to patient after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (dose administered to patient after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. The vial was initially moved to the fridge on 09-Mar-2021 and proposed beyond use date was 08-Apr-2021. The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic. It was reported that each time a vial was put into a cooler, sometimes there was a period of time of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34 or 35 degree Fahrenheit.  On the date of administration, at 09:00 A.M., the temperature recorded was 34 degree Fahrenheit and at 10:00 A.M., the temperature recorded was 30 degree Fahrenheit that has been reached by the vial Temperature recordings were taken using a traceable temperature monitor at every hour. The vial was not in a frozen state at the time of vaccine administration. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature. No treatment information was provided.   This case was linked to MOD-2022-566976 (Patient Link).
Patient has a headache since she received the vaccine; This is a spontaneous report from a non-contactable consumer. A 15-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: unknown) via intramuscular route of administration in the left arm on 13May2021 (at the age of 15-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The concomitant medications were not reported. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 13May2021, after receiving the vaccine, the experienced headache. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. It was unknown whether any therapeutic measures were taken as a result of the reported event. The clinical outcome of the event headache was recovering at the time of this report.   No follow-up attempts are possible; information about lot number cannot be obtained.
Vaginal spotting lasting 3 weeks.  Severe stomach pains  Constant IBS flare ups lasting days to weeks. Diarrhea   Constant need to defecate, almost not making it to toliet
Client reports approximately 10 minutes after administration, numbing in arm, heavy arm, arm cramps at site of administration. Complained of feeling heavy eyes, terrible headache and tight throat. Saw MD and given Benadryl, Naprosyn. Fiorocet, all PRN. All symptoms gone 09/14 at 12 AM except for headache.
No additional adverse effect reported.; ROTATEQ, M-M-R II and VAQTA that underwent a temperature excursion were administered.; This spontaneous report was received from a nurse prescriber and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions, allergies and concomitant therapies were not provided.   On 25-MAY-2021, the patient was vaccinated with improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally (lot # 1707591, expiration date reported as 10-MAR-2022, but upon internal validation established as 11-MAR-2022) (exact dose not provided) for prophylaxis. The administered dose was stored in temperature above 46 Fahrenheit degrees (F) (46.8 F) for 30 minutes. No previous temperature excursion occurred. Digital data logger was involved. No additional adverse effect reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2105USA006607: US-009507513-2106USA003900: US-009507513-2106USA003901:
Headache, right arm soreness I took Tylenol for pain relief.  Symptoms subsided after about 24 hours.
This spontaneous report as received from a physician refers to his wife of unknown age with none pertinent medical history and none drug allergies. The patient was vaccinated with a dose of ZOSTAVAX (lot # not reported) subcutaneously "about 3 years ago", approximately in 2009. No concomitant medications were reported. It was reported that the patient had since then subsequently developed shingles. The patient had experienced 3 outbreaks of shingles. Treatment was given by using VALTREX. And each case of the shingles was "very limited and responded quickly to VALTREX". The outcome of shingles was reported as recovered on an unspecified date. The patient sought for medical attention via an office visit. This is one of several reports received from the same source. Additional information is not expected.
The evening of the day I got the shot, I began to get tired and started to have a sore arm.  Throughout the night, the arm soreness got worse and I got joint pain.  The whole next day, I experienced severe malaise, headache, chills, fever, and joint pain with the site soreness.    The arm pain got worse.  That night, I struggled to sleep.  The whole day after that, I had less malaise and the fever had gone down but the injection site reddened and grew even warmer and more tender.  That evening it was difficult to sleep as the soreness in my arm migrated to the shoulder, armpit and the right side of my chest, along where a bra band would go on the distal right side of the chest.  The next morning (today) the entire armpit area and upper distal right side of the chest were hot and tender.  This afternoon, I palpated the area and noticed at least one swollen lymph node.  My arm still hurts.
my heart rate was 96-110; Pulse Ox Saturation Rate (SP02) rate of 88-93; extreme headache; This is a spontaneous report from a contactable consumer (patient). A 61-years-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: ER8729), via an unspecified route on 11Apr2021 at 22:30 (at the age of 61-years) as dose number unknown, single in the left arm for covid-19 immunisation. The patient medical history included Diabetes II, Hypothyroidism, Hypertension, Hyperlipidaemia, NAFLD. The patient concomitant medications included olmesartan medoxomil (BENICAR), Levothyroxin, Hydrochlorothiazide (HCTZ), Metformin, nifedipine (PROCARDIA) from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 11Apr2021, the patient experienced extreme headache and had Pulse Ox Saturation Rate (SP02) rate of 88-93, her heart rate was 96-110. The events resulted in doctor or other healthcare professional office/clinic visit. The outcome of the events was resolved with sequel.  No follow-up attempts are possible. No further information is expected.
No adverse reaction noted with patient; Temperature excursion in freezer, was instructed vaccines were okay to use; This spontaneous report was received from a certified medical assistant, concerning a 5-year-old male patient.  The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 20-AUG-2020, the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (strength, dose or anatomical location were not reported) with lot # reported as T007359 with expiration date on 29-AUG-2021, administered subcutaneously, for prophylaxis, at a public clinic, with public funds, by a trained operator. It was reported that there was nothing wrong with the vaccine which was used according to the instruction leaflet; however, it underwent a temperature excursion in the freezer before administration and the vaccine provider was instructed that the vaccine was okay to use (product storage error). No digital Data logger was involved. No adverse reaction was noted in the patient.  Lot number T007359 is an invalid lot number for Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2008USA001768:
Patient became pregnant in April 2021.  At 8 week ultrasound on May 21, 2021, displaying signs of early miscarriage.  Repeat ultrasound June 9, 2021 displayed no fetal cardiac activity.  D&C procedure completed June 14, 2021.
Information has been received from a physician and follow up information from a health care professional concerning a 21 year old female patient with no drug reactions/allergies who on 07-MAY-2007 was vaccinated IM in the right deltoid with the third dose of Gardasil (Lot #657617/0384U).  Concomitant therapy included ethinyl estradiol (+) etonogestrel (NUVARING).  On 08-MAY-2007 the patient experienced an injection site reaction of redness, swelling and the area was hot to the touch.  There were three red blotches near the injection site including the injection site.  No labs were performed.  Her outcome was not reported.  Additional information is not expected.
Complaint of elevated temperature/fever, runny nose/congestion, myalgia, and malaise
gotten sick as heck within days of getting the shot; Initial information regarding this unsolicited valid non-serious social media case received from a consumer (patient) on 19-NOV-2020.  This case involves a patient of an unknown demography gotten sick as hell (Illness), when received INFLUENZA VACCINE (Flu shot).  The patient's medical history included Chemotherapy and Radiotherapy.  The patient's past medical treatments, vaccinations and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and expiry date not reported) via an unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient gotten sick as heck within days of getting the shot (illness, non-serious event) within days following the administration of INFLUENZA VACCINE  No laboratories details reported.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the event outcome was unknown.  There will be no information available on batch number for this case.
Within 14 minutes after the vaccine injection patient started itching on face, head, arm, back ,and hand. Rash on hand and lower right side and then went away, .Sweating over body. B/P taken around 2:oopm 120/78,  P- 70. Patient states she is okay now. She drank 3 bottles of water.
pain in shoulder blades; coughing; nerve pain in palm and the soles of feet; nausea; body aches; arm soreness; This case was reported by a pharmacist via call center representative and described the occurrence of pain in extremity in a 66-year-old female patient who received Herpes zoster (Shingrix) (batch number 92M54, expiry date 2nd June 2021) for prophylaxis.   On 15th April 2019, the patient received Shingrix (intramuscular). On 15th April 2019, 12 hrs after receiving Shingrix, the patient experienced pain in extremity. On 16th April 2019, the patient experienced general body pain. On 17th April 2019, the patient experienced nausea. On 18th April 2019, the patient experienced neuralgia. On 19th April 2019, the patient experienced cough. On 20th April 2019, the patient experienced shoulder blade pain. On an unknown date, the outcome of the pain in extremity, general body pain, cough, shoulder blade pain and neuralgia were recovered/resolved and the outcome of the nausea was not recovered/not resolved.   It was unknown if the reporter considered the pain in extremity, general body pain, nausea, cough, shoulder blade pain and neuralgia to be related to Shingrix.  Additional details were provided as follows: The patient received an unspecified dose of Shingrix on left deltoid. Later the day of vaccination, the patient had arm soreness. The day after she experienced body aches, and the day after that she experienced nausea. The day after that she experienced nerve pain on her palms and the soles of her feet. The next day, she experienced coughing. The next day after that, she experienced pain in her shoulder blades. The reporter consented to follow up.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 06-OCT-2014 the patient was vaccinated with an improperly stored dose of GARDASIL (10 X 1 sdv; lot # J002641, expiration date: 04-NOV-2016; dose, frequency and route unspecified). No adverse effects were reported. The storage criteria was refrigerator (R). Celsius conversion of the lowest recorded temperature was 1 (Fahrenheit degree/ Celsius). The total cumulative excursion time was 48 hours with the lowest recorded temperature 1 (Fahrenheit degree/ Celsius) and the type of excursion (R/F) was R. This is one of several reports received from the same source. Additional information has been requested.
I started to get a painful rash on my left torso and at first thought it was a bug bite but then after 48 hrs it got worse and more painful and I realized it was shingles. I have never had shingles and I am healthy and young and so I thought it might be related to getting the vaccine- Maybe COVID vaccine induced it or made me susceptible.  I am nursing a 4 month old to give more information.
Within an hour the area around the injection site turned red and then became hot and hard.  By the next morning the swollen area was larger about three inches in diameter.  Today day 3,  it is still swollen, and a little bit bigger.
Fever (maximum 102F); chest pain,central breast bone lasting approximately 4 hours; This is a spontaneous report from a contactable consumer.   A 23-years-old non pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration, administered in Arm Right on 30Mar2021 12:30 (Age at vaccination 23 years) as dose 2, single for covid-19 immunisation.  Medical history included migraine. Concomitant medications included fremanezumab (AJOVY [FREMANEZUMAB]), depovera. Patient had allergic to amoxicillin. Patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) dose 1 on 09Mar2021 12:30 for covid-19 immunization. The patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 31Mar2021 08:30 The patient experienced fever (maximum 102f), chest pain, central breastbone lasting approximately 4 hours. The patient underwent lab tests and procedures which included pyrexia was (maximum 102f) on 31Mar2021. Patient did not receive any treatment. On an unspecified date in 2021, the patient had recovered from the events.  No follow-up attempts are needed. No further information is expected.
p/vax pt  devel T102.4; c/o sore throat; chills; coated white tongue;  feeling better by 8/29
Experienced severe cold chills whereas my body felt like pins and needles all over including body aches and fatigue. Woke up with night gown damp, so I probably had a low grade fever.
sore throat; headache; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (sore throat) and HEADACHE (headache) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Jan-2022 at 12:00 PM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Jan-2022, the patient experienced HEADACHE (headache). On 10-Jan-2022, the patient experienced OROPHARYNGEAL PAIN (sore throat). At the time of the report, OROPHARYNGEAL PAIN (sore throat) and HEADACHE (headache) outcome was unknown.            Patient took first dose on 01-April-2021 and Second dose 21 day after first dose.Patient said he's not going to see a doctor unless the events get worse. No treatment information was provided by the reporter. No Concomitant medicines were reported.   This case was linked to MOD-2022-448146 (Patient Link).
Pt. received vaccine on 11-14-12. That evening her arm was sore. The next AM it was fine. Then today, 11-15-12, after work her arm was sore again and area of injection was red. ROCEPHIN 1 gram was given to pt at 5:43 PM (for cellulitis (R) arm).
This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NEURITIC PLAQUES (non-serious), outcome "unknown", described as "increased brain plaques"; ASTHENIA (non-serious), outcome "unknown", described as "weakness"; HYPOAESTHESIA (non-serious), outcome "unknown", described as "numbness in legs"; SPINAL PAIN (non-serious), outcome "unknown", described as "spine pain". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: Patient has increased brain plaques, weakness and numbness in legs, spine pain after receiving COVID vaccine Doctor said this MRI shows that consumer have more splotches than the previous MRI, and so, the medicine hasn't been working perfectly, none of them do, but as consumer have noticed, consumer have been having more and more symptoms. This MRI certainly supports the idea of switching. Causality was not reported. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Some food smells turned to skunk-like. I was 6 weeks pregnant at the time, and it was a few days after my 1st vaccine dose when some food smells turned very sour. I have been pregnant two times previously, and neither of those pregnancies resulted in modified taste or smell. I lost my taste and smell initially in May 2021 when I presumably had COVID-19, but I didn't ever test to confirm. Loss of taste and smell were the only symptoms. My taste and smell were recovering slowly when I became pregnant and received the 1st dose of the vaccine. I had not experienced a bad smell or taste up to that point.  A few days later my smell started to turn sour. I have experienced some pregnancy related nausea and food aversions simultaneously.  My estimated date of delivery is 05/08/2022.
This spontaneous report was received from a nurse referring to an unspecified number of patients of unknown genders and ages. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided. On an unknown date, the patients were vaccinated with an improperly stored dose of GARDASIL with a Lot # reported as L035105 with an expiration date of 14-MAY-2017 (strength, dose and route of administration were not reported) for prophylaxis, however no adverse effects reported.  It was reported that from 23-DEC-2016 to 31-DEC-2016, the vaccine was exposed to a temperature of 32 to 36 Fahrenheit degrees range (0 to 1 centigrade degrees) for a time frame of 177.5 hours (for 6 cycles); from 03-JAN-2017 to 31-JAN-2017, the vaccine was exposed to the same temperature for a time frame of 464.5 hours (for 21 cycles); from 02-FEB-2017 to 28-FEB-2017, the time frame was 409.5 hours (for 16 cycles) and from 01-MAR-2017 to 15-MAR-2017, the time frame was 61 hours (for 6 cycles). The temperature excursion was recorded by a data logger and no previous excursions were reported for the vaccines. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1704USA004439: US-009507513-1704USA004438: US-009507513-1704USA004440: US-009507513-1703USA010028:
This spontaneous report was received from a pharmacist and refers a 61 year old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, drug allergies or reactions and concomitant medication were not reported. It was stated that the pharmacy received the ZOSTAVAX on 15-JUL-2016. On 14-NOV-2016, the patient was vaccinated with an improperly stored dose of ZOSTAVAX 19400 plaque-forming unit (PFU) injection, subcutaneously, 0.65 ml, lot # M014310, expiry date 26-MAY-2017 (anatomical location was not specified) for prophylaxis. On 22-MAR-2017, the pharmacy was audited by The Board of Pharmacy. The freezer temperature where ZOSTAVAX was stored was registered by the pharmacy thermometer as 2 Fahrenheit degrees, however the auditor's thermometer registered the temperature as 9 Fahrenheit degrees which was considered as a temperature excursion. The Board of Pharmacy auditor determined that the pharmacy's freezer thermometer should have been calibrated. Seven of the 10 doses of ZOSTAVAX that had undergone the temperature excursion had been administered to 7 patients between July 2016 and January 2017 (also reported as "over an 11 months period"). The remaining 3 doses were sent back for disposal. There was no previous temperature excursion. No adverse effect were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information is not expected as all follow up information has been received. Sender's Comments: US-009507513-1705USA006382: US-009507513-1703USA010654: US-009507513-1705USA006384: US-009507513-1705USA006385: US-009507513-1705USA006380: US-009507513-1705USA006381.