chrisvoncsefalvay/vaers-outcomes huggingface dataset:
tired; passed out; very very sick; felt like she had a bad flu; bad aches in her bones; bad aches in her joints; Her temperature was 100.3 °F; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (passed out) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 20-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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. On 21-Apr-2021 at 9:00 PM, the patient experienced LOSS OF CONSCIOUSNESS (passed out) (seriousness criterion medically significant), VACCINATION COMPLICATION (very very sick), INFLUENZA LIKE ILLNESS (felt like she had a bad flu), BONE PAIN (bad aches in her bones), ARTHRALGIA (bad aches in her joints) and PYREXIA (Her temperature was 100.3 °F). On 22-Apr-2021, the patient experienced FATIGUE (tired). On 22-Apr-2021, LOSS OF CONSCIOUSNESS (passed out), VACCINATION COMPLICATION (very very sick), INFLUENZA LIKE ILLNESS (felt like she had a bad flu), BONE PAIN (bad aches in her bones), ARTHRALGIA (bad aches in her joints) and PYREXIA (Her temperature was 100.3 °F) had resolved. At the time of the report, FATIGUE (tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Apr-2021, Body temperature: 100 (High) 100.3 °F.         No concomitant medication details was provided. No treatment medication details was provided.  She was vaccinated both times in the same facility.  Company Comment  : 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. Further information has been requested.   This case was linked to MOD-2021-060799 (Patient Link).; 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. Further information has been requested.
Injection site pain; muscle pain; joint pain; tingling; headache; sensitivity to light and sound; chest tightness; body aches; This is a spontaneous report from a non-contactable consumer, patient. A 31-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: En6204), via an unspecified administrated in the left arm on 27Mar2021 at 10:45 hours as a single dose for COVID-19 immunisation (at the age of 31-years-old). Medical history not provided. Concomitant medications included metformin (MANUFACTURER UNKNOWN), spironolactone (MANUFACTURER UNKNOWN), sertraline (MANUFACTURER UNKNOWN) for an unknown indication. Previously patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6205), via an unspecified administrated in the left arm on 4March2021 as a single dose for COVID-19 immunisation (at the age of 31-years-old). The patient did not receive any other vaccines within 4 weeks prior to the vaccine. Since the vaccination, the patient was not tested for COVID-19. On 27March2021, at 12:45 hours patient experienced injection site pain, muscle pain, joint pain, tingling, headache, sensitivity to light and sound, chest tightness, body aches. Prior to vaccination, the patient was not diagnosed with COVID-19. Therapeutic measures were not taken as a result of the event. Clinical outcome of the Injection site pain, muscle pain, joint pain, tingling, headache, sensitivity to light and sound, chest tightness, body aches was recovering at the time of reporting. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Mild pain at injection site on evening of day one and into day 2 Day 7 -  March 31, 2021 Bright Dark Red Rash appeared on RIGHT thigh and into groin area, from front of leg around to the back.  Skin had oval spots and areas with with no red coloring at all, and skin was extremely sensitive, like a bad sunburn.  The rash area was completely around the leg from front to back. Day 8 - Injection site started to itch and became very inflamed with raised edges and a couple of the same oval patches that were not red. Day
Although patient "did not feel" the shot, a few hours later it felt tender and looked bruised & swollen. There was also pain that went up the shoulder to the neck area. She has been using cold compress, then Ibuprofen. Today the lump is gone and pain is better (pain was worse first 24 hours). Advised patient to see her doctor if not all better; discussed hi-dose versus quad -will try quad next year and changed to right arm...left arm weak from stroke 2 yrs. ago.
This spontaneous report as received from a other healthcare worker refers to a female patient of unknown age. On an unspecified date in approximately March 2013, "about a year ago", the patient was vaccinated with first dose of GARDASIL (injection, lot#, dose, route and duration were unspecified). Patient would receive her second dose of GARDASIL (injection, lot#, dose, route and duration were unspecified) today, 27-MAR-2014. No adverse effect reported. The outcome was unknown. Additional information has been requested.
TDap vaccination administered at prior command February 10, 2020. Within a few hours after vaccination, I reported to Medicine team that my arm was unusually sore and numb (tingly sensation). I was advised to give it a few days to subside. Numb/tingly sensation was sporadic (would come and go from time to time since then) in addition to crepitus of L shoulder. Once arrived at new/current command, after receiving the Influenza vaccination November 23, 2020, my L arm began to experience numb/tingly sensation, but more constant in addition to stiffness and increased crepitus. Since Influenza vaccination, my L arm has had constant tingly/numb sensation. I was seen January 2021 for the chief complaint and visit is noted in my record.
administrated / expired dose / on April 30 2021. /expired on June 30 2020.; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a patient who received Flu Seasonal QIV Dresden (Fluarix Tetra 2019-2020 season) (batch number ZY975, expiry date 30th June 2020) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 30th April 2021, the patient received Fluarix Tetra 2019-2020 season and Fluarix Tetra Pre-Filled Syringe Device. On 30th April 2021, unknown after receiving Fluarix Tetra 2019-2020 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional information was provided as follows:  The age at vaccination was not reported. On 30th April 2021, the patient received Fluarix tetra vaccine which was already expired on 30th June 2020. No adverse events were reported. No patient identifiers were reported. The reporter consented to follow up.
Arm soreness; Fever; Muscle pain; Joint pain; Fatigue; This is a spontaneous report from a contactable consumer. A 47-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730) via an unspecified route of administration in the left arm on 21Apr2021 at 10:00 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19 (Prior to the vaccination, the patient was diagnosed with COVID-19). Concomitant medications included losartan (MANUFACTURER UNKNOWN), amlodipine (MANUFACTURER UNKNOWN), fluoxetine hydrochloride (PROZAC), multi vitamin and magnesium (MANUFACTURER UNKNOWN); all from an unknown date for unknown indication and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the left arm on 30Mar2021 at 10:00 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. On 21Apr2021 at 12:00, the patient experienced arm soreness, fever, muscle pain, joint pain and fatigue. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of reported events which included treatment with paracetamol (TYLENOL). The clinical outcomes of event arm soreness, fever, muscle pain, joint pain and fatigue were resolved on an unknown date in Apr2021.   No follow-up attempts are needed. No further information is expected.
hospitalized; unable to take his second vaccine within the recommended window; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of HOSPITALISATION (hospitalized) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HOSPITALISATION (hospitalized) (seriousness criterion hospitalization) and PRODUCT DOSE OMISSION ISSUE (unable to take his second vaccine within the recommended window). At the time of the report, HOSPITALISATION (hospitalized) and PRODUCT DOSE OMISSION ISSUE (unable to take his second vaccine within the recommended window) outcome was unknown. Not Provided      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 of a 65-year-old male patient who was hospitalized (reason not provided) and  was unable to take his second vaccine within the recommended window(product dose omission).  There is not enough information to assess the event of hospitalization as reason for hospitalization was not provided.  The event of product dose omission is assessed as not applicable.; Sender's Comments: This case of a 65-year-old male patient who was hospitalized (reason not provided) and  was unable to take his second vaccine within the recommended window(product dose omission).  There is not enough information to assess the event of hospitalization as reason for hospitalization was not provided.  The event of product dose omission is assessed as not applicable.
Information has been received from a registered nurse (RN) concerning an elementary aged child who was vaccinated with a dose of Varivax. The RN reported that in February 2006, the patient developed breakthrough chickenpox which was considered to be a light, mild case. Unspecified medical attention was sought. At the time of this report, the outcome was unknown.
Cardiac symptoms, iirregular heartbeat, chest tightness, nausea. Urgent Care, Emergency room and cardiologist. Various Tests and medication.
Painful at time of injection - (Hasn't happened with previous flu vaccines). The next day she felt faint and almost passed out. It lasted about 15 min. splashed cold water on face and rested until feeling went away. Upper legs hurt and nausea. Severe pain.
Patient experienced bad migraine for 8 hours that started approximately 12 hours after receiving 1st moderna shot.
Moderna COVID-19 Vaccine EUA Shortness of breath, chest pain, cutaneous hyperesthesia, nausea, insomnia, injection site pain, muscle pain, chills, diaphoresis, lightheadedness, joint pain, headache
Rash, pain, swelling and itch at the injection site 11 days after receiving the shot
From initial information received on 11/07/2003 from a healthcare professional regarding an adverse event occurring in the USA, it was reported that an 11 year old male patient received a dose of Fluzone SV '2003-'2004 USP, lot number U1097AA, administered intra-muscularly in the left deltoid on 11/06/2003.  Immediately after receiving the vaccination, the patient developed wheezing and numbness in the left arm down to the wrist.  Treatment included Albuterol via hand held nebulizer.  The symptoms resolved within 15 minutes and the patient was observed for 45 minutes.  The patient was to follow up with an allergist.  The patient recovered from these events.
Patient was administered first dose of shingrix on 9/9/19 and reported an adverse event on 9/12/19.  Patient sought medical treatment and was diagnosed as having cellulitis. Patient was treated with antibiotics.
Pt presented to ED with severe back pain and unable to bear weight to bilateral lower extremities. Pt stated sudden onset of bilateral pelvic numbness on 1/17/2023. C/o urinary retention. Diagnosis: Back pain, back pain with sciatica, flaccid paraplegia, guillain-barre syndrome.
head aches, fever, sinus pain & pressure, dizziness,  vertigo,  shaking, hard time talking.
This spontaneous report as received from a pharmacist via representative refers to himself. The pharmacist reported that he was administered ZOSTAVAX (dose and lot# not reported) intramuscular 3-4 years ago. No adverse effects reported. At the time of reporting, the patient outcome was unknown. Additional information is not expected. Update (16-APR-2013): Additional information received from a pharmacist who is also the patient. On an unspecified date in 2009 the patient received vaccine ZOSTAVAX (0.65 ml, intramuscular). He also reported that after receiving the ZOSTAVAX the injection site never healed properly. He continually gets a scabby area on the arm where the ZOSTAVAX was administered. He stated that the area gets crustier and then sloughs off and leaves a very bright pink area of skin. This had occurred multiple times. He has not discussed it with his physician. The outcome of injection site never healed properly and continually gets a scabby area on the arm where the ZOSTAVAX was administered was reported as not recovered/not resolved. The relatedness of injection site never healed properly and continually gets a scabby area on the arm where the ZOSTAVAX was administered is unknown for ZOSTAVAX. No further information available. Additional information has been requested.
Vaccine given on (L) arm deltoid @ 3:35pm Client reported at 3:40 that her body is shaking, rapid heartbeat, dizziness at 3:40. Denied any shortness of breath or chills. BP 128/44 pulse 78 Respiration 18. Symptoms lasted 5 minutes, later at 3:55 Client stated her throat had felt strange but that she no longer felt it. Client Remain in clinic for observation for 45 minutes. Client Denied any further symptoms. Stating feels fine. 01/07/21 Phone call spoke with client she states the symptom Never returned and feels fine.
lump in armpit and sore; sore collar bone swollen on side that received vaccine; lymph node and collar bone swollen; collar bone swollen; fever; chills; shakes; This is a spontaneous report from a contactable nurse. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 21Dec2020 at single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient stated she was noticing possible side effects in Dec2020, with lymph node and collar bone swollen, fever, chills, shakes, this morning (23Dec2020) lump in armpit and sore collar bone swollen on side that received vaccine. The action taken in response to the events for bnt162b2 was not applicable. The outcome of events was unknown.  Information on the lot/batch number has been requested.
Patients were administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021; Patients were administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patients were administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patients were administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) in an 88-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jan-2021 at 11:13 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 11-Jan-2021 at 11:13 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patients were administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients were administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patients were administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patients were administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 88.36 years.  No concomitant medication were provided.  On 11-Jan-2021, 9 vials were moved to clinic.   On 08-Jan-2021, the vaccines were moved to fridge.  Proposed beyond use date was 07-Feb-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 Fahrenheit.  On the date of administration, at 02:00 P.M., the temperature recorded was 35 Fahrenheit that has been reached by the vial.  Temperature recordings were taken using a brand 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 medication was provided.   This case was linked to MOD-2022-566976 (Patient Link).
On Friday morning, February 19 around 9 am, patient felt like he was biting his lip but didn't say/do anything about it.  He got up and got dressed, went about his day.  Around 12:30 his nephew saw him and commented that his left eye was puffy and red, his face was swollen and drooped and he looked like he was having an allergic reaction of some kind.  At that time, his speech became slurred.  They got a neighbor, who is a nurse, to come over. She recommended medical attention.  They went to an urgent care center and were immediately sent to the hospital.. Left side of his face was drooping and his speech was slurred.  There were no cognitive issues.  Arrived at hospital around 1:30. He was assessed immediately for a stroke and it was determined that he had not had a stroke.  Bell's Palsy was diagnosed.  He was given a steroid injection at the hospital and given a Medrol dosepak to begin on Saturday, Feb. 20 and sent home.   As of today, Monday, February 22, his symptoms are improving.
Moderna # 1 given on 7/7/22 and Moderna # 2 vaccine given on 7/28/22 which was given early. Patient will need to be revaccinated after 8/25. This because the first dose given on 07/07/22 is now invalid. The new 1st dose will be the one given on 07/28 and patient will need to be scheduled for 2nd dose after 08/25.   No adverse S&S at this time.
One week after the first dose of the Pfizer vaccine , On 2/9/2021 I developed severe stiffness in both legs, difficulty climbing stairs and joint pain on my left leg. On 02/25/2021 , I  got a Very sharp pain  on the left leg and in the area of the knee. I was  unable to move and walk for over a week. The pain receded somewhat  in the following weeks but never completely. The knee and join pain has worsened again since 4/1/2021 and I have scheduled XRays and a visit with an orthopedist .  Prior to the vaccination I was in very good health condition. taking
Nerve pain; Shingles after receiving first dose; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 82-year-old male patient who received Herpes zoster (Shingrix) (batch number 9472F, expiry date 14th October 2022) for prophylaxis.   The patient's past medical history included lymphoma (patient was diagnosed with lymphoma prior to starting the series).   On 27th May 2021, the patient received the 1st dose of Shingrix. In June 2021, 1 month after receiving Shingrix, the patient experienced shingles. On an unknown date, the patient experienced nerve pain. The patient was treated with gabapentin and acyclovir. On an unknown date, the outcome of the shingles and nerve pain were not recovered/not resolved.   It was unknown if the reporter considered the shingles and nerve pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The pharmacist stated that, the patient who received the first dose of Shingrix 6 months ago, had lymphoma and exhibited shingles about a month after receiving the first dose.  On an unknown date, less than 9 months after receiving Shingrix the patient experienced nerve pain The patient was treated with Gabapentin and Acyclovir.  The patient was still being treated with Gabapentin for the nerve pain. The reporter consented to follow up.
Reports symptoms  began 6pm , 1 hour after receiving vaccination, headache and feeling bumps on her tongue and roof of mouth, taste was off.  on 3/3/21 midnight was awakened from sleep from pain in all of her joints, back and neck.  Experienced dizziness and fatique  in the morning.
RECEIVED ONLY 2.5ML OF THE JANSSEN COVID-19 VACCINE; OFF LABEL USE; This spontaneous report received from a health care professional concerned a 35 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211A21A, and expiry: 14-DEC-2021) 2.5 ml, administered on 14-NOV-2021 for prophylactic vaccination. No concomitant medications were reported. On 14-NOV-2021, the patient experienced received only 2.5ml of the janssen covid-19 vaccine. On 14-NOV-2021, the patient experienced off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the received only 2.5ml of the janssen covid-19 vaccine and off label use was not reported. This report was non-serious.