chrisvoncsefalvay/vaers-outcomes huggingface dataset:
LATER IN DAY 8/10/09 UPPER LT ARM RED & SWOLLEN. PROGRESSED TO BELOW ELBOW. LT HAND SWOLLEN AND "PURPLE". PAIN IN ARM. FEVER 8/10/09 THROUGH 8/13/09 NOT OVER 104.2 CHILD SEEN AT ER BY A NURSE. DETERMINED WAS ALLERGIC REACTION GAVE BENADRYL PO & TOPICAL & TYLENOL IN 2 DAYS ARM WAS WELL. NEVER HIVES OR RESPIRATORY REACTION.
Really tired; A little bit of muscle pain; Feel kind of week; Headache; This case was reported by a consumer via call center representative and described the occurrence of fatigue in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20th November 2019 19:00, the patient received the 1st dose of Shingrix. In November 2019, less than a day after receiving Shingrix, the patient experienced fatigue, myalgia, weakness and headache. On an unknown date, the outcome of the fatigue, myalgia, weakness and headache were unknown.   It was unknown if the reporter considered the fatigue, myalgia, weakness and headache to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. A day before reporting in the evening at about 7 PM, the patient got Shingrix On the day of reporting, the patient was really tired, felt kind of week, had a little bit of muscle pain and a headache. The patient asked whether these were normal side effects and how long would these symptoms last.
Systemic: already received J and J and did not tell pharmacy, Additional Details: pt received dose of J & J in April 2021 from another pharmacy.  Did not report when making appointment for Pfizer
Life long endurance athlete/long distance runner.  At the time of vaccination I had the ability to run 12-16 miles at a 9:45-10min/mile pace.  Starting 2 weeks after the vaccination, I was no longer able to even run 1 Mile.  My heart rate was where it should be (160s), but I felt as though I could not breath and had to stop.  This has continued for the past 6 months and I have just recently been able to run 2 miles, anything beyond this is still impossible,  I have trackable running data as recorded by my watch that can be shared for before vs after running abilities.
Legs were hurting; Everything was hurting my lower and my middle part of the body; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient stated, "It is about two things one Pneumonia Shot (Unspecified Pneumonia Shot) and then Covid-19 Shot. This first one is the Pneumonia Shot. I had the Pneumonia shot (for immunization), the second Pneumonia shot in 20Oct2020 and I had an adverse reaction to that shot." Patient then stated, "What I am concerned is about the Covid-19 Shot. I had the second one. What happened was I walked out to the doctor's office. I just started feeling that the back of my legs were hurting. I sat down in the car, everything was hurting, my lower and my middle part of the body and then I got in there to get checked with the doctor again the second time. I went in there and they checked me up and I had no blood pressure it didn't gone up and I didn't have the temperature, my bowels did not change and then they kept me in there for an hour or so to make sure that I was okay to leave and then I just left. Since this a Pfizer product the Covid 19 shot (incomplete sentence)." The outcome of the events was unknown.  Information on the Lot/Batch Number has been requested.
Medical assistant calling to report a temperature excursion that occurred 8/14/2020 which involved the following products: GARDASIL9, PEDVAXHIB, RECOMBIVAX, ROTATEQ. Per caller, "it would be possible that at least 100 patients have received vaccines; This spontaneous report was received from a medical assistant, concerning a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies or concomitant medications were not reported.  On 21-AUG-2020, the patient was vaccinated with an improperly stored doses of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally as prophylaxis (lot # 1660991 with expiration date 27-APR-2021) (strength and frequency were not reported) and with haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) as prophylaxis (lot # T011167 with expiration date 27-MAY-2022) (strength, frequency, route of administration and anatomical location were not reported).  The improperly stored doses of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) and haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) experienced a temperature excursion of 35.4 Fahrenheit degrees (°F) for the time frame of 20 minutes without previous temperature excursions. It was confirmed that a digital data logger was involved.  This is one of several cases from the same reporter. ; Sender's Comments:  US-009507513-2009USA006106:
Within first 12 hours, felt very tired, leg, back and shoulder muscles ached. Experienced on and off chills, low grade fever.  Bad headache, dizziness and light headedness.   All symptoms lasted 4 days.   I handled this at home without medical intervention.
After the vaccines lost temperature they were administered; A spontaneous report was received from a healthcare professional concerning a 75-year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the event, after the vaccines lost temperature they were administered.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 11 Jan 2021, a refrigerator in a vaccine clinic lost power and rose up to room temperature overnight. At approximately 9 p.m., the vaccines inside the refrigerator reached room temperature.  On 12 Jan 2021, after the vaccine lost temperature, the patient received their first of two planned doses of mRNA-1273 (Lot number: 027L20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.  No treatment information was provided.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.  The event, after the vaccines lost temperature they were administered, was considered resolved on 12 Jan 2021.; Reporter's Comments: This case concerns a 75-year-old male patient who received their first of two planned doses of mRNA-1273 (Lot: 027L20A), reporting Out of specification product use.
Partial loss  of hearing in right ear and minor reduction in hearing in left ear for past three days. Condition continues.
First day I have a very mild headache and my arm was very sore. That night I started to feel achy and sore and had cold chills. Sunday, the 7th, I still had the headache, achy and sore body, and was constantly really hot or feeling really cold. At one point late Sunday night I was feeling really sore and it hurt to move and I was burning up then freezing. Today I am feeling much better
Severe pain in my left arm. On Sunday Feb 28 I still had severe pain in my arm but also my whole body started hurting and I a had a headache. Monday March 1 vomiting and body aches. The pain in my arm has gone away.
This spontaneous report was received from an unspecified source via published article referring to a 900 unspecified children of unknown age and gender. No information regarding the patients' medical history, concurrent conditions or concomitant therapies was provided. On an unknown dates, the patients were vaccinated with a dose of M-M-R II (strength, dose number, route, frequency, lot number and expiration date were not provided)  for prophylaxis, through a free or low-cost vaccine program. It was reported that during a routine compliance visit, problems with refrigeration temperatures were discovered. Also, it was reported that the vaccines were not stored properly at the right temperatures, which possibly reduced their effectiveness and the temperature problems may had occurred as early as November 2014. The children who should be evaluated for revaccination were vaccinated between November 2014 and 28-JUL-2016. Additionally, it was reported that the possible ineffective vaccines did not pose any health dangers to the children who received them but those children may not be fully protected against vaccine-preventable diseases. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1701USA005965: US-009507513-1701USA005966: US-009507513-1701USA005968: US-009507513-1701USA005969: US-009507513-1701USA005964: US-009507513-1701USA005967:
Extreme chills fevers Sneezing Runny nose watery eyes Fatigue Body aches . Extreme chills And fatigue started 34 hours after shot . Sneezing started 48 hours after the shot Runny nose watery eyes And body aches Started 56 hours .
Fatigue, body aches, fever the same night patient received vaccine.  The next day there was tenderness in the arm and then swelling got worse.  This lasted for days so patient went to see the doctor and was diagnosed with cellulitis.  Swelling, pain, and tenderness has improved with 2nd course of antibiotics.
suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The reporter was patient's son/ daughter. The age at vaccination was not reported. The patient got shingles vaccine and had a terrible case of shingles.  The ad shouldn't say you would not get shingles. This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory confirmation of shingles were not provided.
Nausea; Vomiting; diarrhea; headache; inflammation; fatigue; This is a spontaneous report from a non-contactable other healthcare professional (Patient).  A 53-years-old female patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and expiry date was not reported), via an unspecified route of administration on an unspecified date as unknown, single dose for covid-19 immunisation. Medical history included allergies: shellfish, cashews, a few antibiotics. Concomitant medications included ergocalciferol (VIT D), melatonin, zinc and vitamin c (ascorbic acid). The patient did not receive any vaccination within 4 weeks of covid vaccine administration. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 30Jan2021, at 18:00 the patient experienced Nausea, Vomiting, diarrhea, headache, inflammation and fatigue. There was no treatment received for reported events. Outcome of the events Nausea, Vomiting, diarrhea, headache, inflammation and fatigue was reported as recovering.  No follow-up attempts are possible. Information on the lot/batch number cannot be obtained.
A vaccine dose was administered to a homebound patient. The dose was prepared and stored in a portable cooler with a data logger by health department. Paramedics administering the dose did not recognize the cooler temperature was below the temperature storage range of the vaccine. The vaccine was administered without adverse effects to the patient during the 30 minute period the patient was observed.
Injection site was sore after the injection.  The site continued to increase pain and is swollen and warm to the touch.  stiff to  move
has not had the cycle/started to spot a little bit; This is a spontaneous report from a contactable consumer (patient's husband).   A female patient of an unspecified age received bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation.  The patient's medical history and concomitant medications were not reported. The reporter stated his wife (patient) got the COVID-19 vaccine, has not had her period and they started getting little worried if she should go to the doctor. She never had this problem before. They were just wondering is this common with the side effects or anything like that. When paraphrased the concern, reporter stated, the patient  has not had the cycle in mid. She has started to spot a little bit, that is it. So they have been worried. The outcome of the event was unknown.   Information on the lot/ batch number has been requested.
High fever; Chills; Swelling; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of   in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20a) for COVID-19 vaccination.     The patient's past medical history included COVID-19 on 06-Apr-2020. Concurrent medical conditions included Blood pressure. Concomitant products included METFORMIN, LEVOTHYROXINE, ATORVASTATIN, OLMESARTAN, MELOXICAM (MELOXICAN) and MULTIVITAMIN [VITAMINS NOS] for an unknown indication.    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Received my 1st dose of Pfizer COVID vaccine on 7/23/21 and shortly after began to feel palpitations and indigestion with occasional regurgitation of stomach acids.  The palpitations resolved a few days later, but indigestion is persistent on a daily basis and accompanied by stomach pains occasionally.  Indigestion worsens at night when I'm lying down, regardless of position.  I take Rolaids for discomfort but it's only a temporary relief.  The morning of my 2nd dose, I felt okay, but indigestion began about 20 minutes after receiving 2nd dose of vaccine.  I tried eating, but that made it worse.  In addition, minutes after receiving the 2nd dose, I began to experience pain in my left neck.  I did report it to the staff nurse while under the 15 minute observation, but they said to take Tylenol when I got home.    I took 1,000mg of extra strength Tylenol when I got home, and pain decreased about 30 minutes later but I can still feel discomfort in that area.
Large rash, swelling, hot to touch at injection site. Size currently is bigger than my hand and continuing to spread.
After giving immunizations instructed Mom to wait with both children for 15 mins in our vaccination room and when returning to give mother the visit summary at 11:40am , baby was sitting in infant seat sound asleep, tired to arouse baby with sternal rub- baby still sleeping, checked pupils with bright light, baby still sleeping. Mother reported that baby's nap time is usually around this time of day and she had been up since 6 am and last feeding was at 10:30am . Asked RN to please hold baby and stay with mom , retrieved our NP and our volunteer to please help assess baby in vaccination room. Applied child size bp cuff on left thigh to obtain bp reading and then baby began to cry and was easily aroused. Baby was then placed in mother's arms and baby was smiling and awake. Informed with help from translating RN that should mother see any changes in baby's respirations or behavior to please go to er or call 911 for evaluation . Let her know that usually in the first 15 mins post vaccination that is when a reaction is likely to occur. Baby Awake and alert and responding to her mother. Discharged in stable condition with mom.
improperly stored vaccine administered to patient; This spontaneous report as received from a nurse refers to a patient of unknown age and gender. Pertinent medical history, drug reactions, allergies and concomitant medications were not reported.  On 26-AUG-2020, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot number T007396, expiration date: 29-AUG-2021) 0.5 ml (route of administration was not provided). The vaccine was stored in temperature of 16.07 degree Fahrenheit for 25 minutes. There was no previous temperature excursion. Digital data lodger was involved.
Urticaria over face, chest, arms, legs back, extreme pruritus, facial swelling, right thigh swelling that developed rapidly over the morning of her reaction, on the day after her visit. Treatment included BENADRYL, DECADRON 4mg oral, greater than 1 hour observation in office until improving, followed by a 1mg/kg bid prednisolone course for 5 days. Subsequent allergist testing revealed the previously unknown allergies and she will receive subsequent MMR under observation at the allergist's office.
soreness of the arm; Initial information received on 27-Nov-2019 regarding an unsolicited valid non-serious case received from a pharmacist vi other company Merck.  This case involves an unknown demographic patient who experienced soreness of the arm (pain in extremity), while he/she received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  Medical history, past medical treatment, past vaccination and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot number and other dosing details were not reported).  On an unknown date, the patient experienced non-serious soreness of the arm (pain in extremity) following the day of administration of INFLUENZA QUADRIVAL A-B VACCINE.  Details of laboratory data not reported.  Final diagnosis was soreness of the arm.   It was not reported if the patient received any corrective treatment.  On an unknown date, the patient had recovered from the event.  Information on the batch number was requested.
This spontaneous prospective pregnancy report as received from a consumer (patient's husband) refers to a 28 years old female patient. The patient had no pertinent medical history or drug reactions/allergies. In 2012 (exact date unspecified, during October and November of 2012) the patient was vaccinated with a dose of VARIVAX (Merck) (dose, route and lot # unspecified), M-M-R II (dose, route and lot # unspecified), TD vaccine (manufacture unknown) (dose, route and lot # unspecified) and influenza virus vaccine (unspecified) (manufacture unknown) while pregnant with LMP (last menstrual period) of approximately 23-OCT-2012 (reported as about 5 weeks ago) and an EDD (estimated delivery date) of 30-JUL-2013. Initial exposure to VARIVAX (Merck), M-M-R II, TD (manufacture unknown) and influenza virus vaccine (unspecified) (manufacture unknown) was at 5 weeks. The patient was "fine" and had not experienced any adverse effects. No treatment was given for adverse events. The patient was maintaining the pregnancy. The patient had done home pregnancy test (in 2012, exact date unspecified) and did not seek medical attention. Follow-up attempt has been made but the correspondence was returned due to not deliverable as addressed unable to forward. Additional information has been requested.
Nine hours of significant pain in major joints of my body shortly after vaccination with Shingrix.  After vaccination I experienced discomfort and acceptable pain around the injection area. About three hours later significant pain developed in my left shoulder then appeared in right shoulder, elbows, left wrist, hip joints, and finally stopping in the knees - over a period of 9 hours. At that point the significant pain was replaced by discomfort (except for left knee) and a headache.
2 patients received vaccine from vial that was not swirled before administering; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a health care professional and describes the occurrence of WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (2 patients received vaccine from vial that was not swirled before administering) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Apr-2021, the patient experienced WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (2 patients received vaccine from vial that was not swirled before administering). On 30-Apr-2021, WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (2 patients received vaccine from vial that was not swirled before administering) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to US-MODERNATX, INC.-MOD-2021-109462 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-109462:Patient 2
On 1/13/2021, this patient received her 1st dose of Moderna COVID vaccine. The next day, she had a sore left arm where she was given the injection. On 1/15, she developed an approx. 5cm x 3 cm red raised lesions surrounding injection site on L. upper arm. Warm to touch, blanches. No weakness, limits to ROM, strength MAE 5/5. No hx of vaccine allergy, hypersensitivity or anaphlaxis.
This spontaneous report as received from a pharmacist refers to a patient of unknown age. On an unknown date "6 days ago" (on 26-APR-2013) the patient was vaccinated with ZOSTAVAX (lot number, dose, route and injection site were not reported). Other suspect therapies included MEDROL. At the time of report the patient had been prescribed a MEDROL dose pack for unspecified symptoms. The outcome was unknown. The action taken and causality was not provided at the time of report. It was unspecified if the patient sought any medical attention. Additional information has been requested.
Swelling; restless arm feeling; hematoma; blotchiness; Injection site rash; This case was reported by a nurse via call center representative and described the occurrence of injection site swelling in a 19-year-old female patient who received Men B NVS (Bexsero) (batch number ABX794AZ, expiry date 31st August 2020) for prophylaxis.   On 17th July 2019, the patient received Bexsero (intramuscular). On 17th July 2019, less than a day after receiving Bexsero, the patient experienced injection site swelling, restlessness, hematoma, blotchy and injection site rash. On an unknown date, the outcome of the injection site swelling and hematoma were recovering/resolving and the outcome of the restlessness was not recovered/not resolved and the outcome of the blotchy and injection site rash were recovered/resolved.   It was unknown if the reporter considered the injection site swelling, restlessness, hematoma, blotchy and injection site rash to be related to Bexsero.  Additional details were reported as follows: The reporter stated that, the patient's mother informed about swelling in her daughter's arm after the injection and blotchiness at the injection site like a rash. The patient had a restless arm feeling since getting the vaccine. The patient had a hematoma about the size of a golf ball and a little under the injection site.