chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pain, swelling, redness to left shoulder down arm, tingling down arm, site warm to touch could not lift her arm up without 8/10 pain.
Initial report received from a nurse on 18 Mar 2010: This patient inadvertently administered FLUVIRIN (expiry date: Feb 2010) (Batch no.: 1009234P), intramuscular, expired vaccine on 18 Mar 2010. No adverse effects were reported after administration. The outcome of the event was not reported. Non-significant follow-up was received on 18 Mar 2010 with no new information provided.
Myalgia, NauseaVomiting, fatigue, toe pain, left great toe swelling, loss of appetite Narrative:
feeling tired; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (feeling tired) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FATIGUE (feeling tired). At the time of the report, FATIGUE (feeling tired) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  Treatment information was not provided.
pt devel redness & swelling/induration 12 hrs p/vax;also had 100 temp;area of induration at maximum was 10cm x 13cm ( @ site of DTP shot);tx w/Nafcillin for cellulitis;
mom states leg red, swelled-pt crying continously; given APAP & applied warm wash cloth to area; No relief p/2 hrs; pt referred to MD;
Acute pancreatitis; This is a spontaneous report from a contactable physician's assistant (retired) reporting on behalf of herself.  A 67-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration administered on arm right on 06May2021 08:15 (Batch/Lot Number: EW0164) as 2ND DOSE, SINGLE for COVID-19 immunization at the hospital.  The patient does not drink alcohol.  Concomitant medications were not reported. She had no prior vaccinations (within 4 weeks). The patient received the first dose of PFIZER-BIONTECH COVID-19 VACCINE on 15Apr2021 (lot#: EW0151, expiration: 31Jul2021) on the right arm as COVID-19 immunization.  Then, the patient had her 2nd dose on 06May2021 08:15. On 09May2021 15:00 (also reported as 72 hours after the 2nd dose), the patient had acute pancreatitis out of the blue. The patient was brought to the emergency room and was hospitalized for 4 Days (09May2021 until 13May2021). She mentioned that she has no previous history of pancreatitis. She had labs drawn 2 weeks prior to the hospitalization (Apr2021) and there were no indications of any problems on the screening labs. Sje also had a CT scan in May2021, and there was no evidence of stones.  She stated that the event was pretty serious and debilitating.  She received support with IV fluids and pain medication until the pancreas settles down. The patient recovered from the event on 13May2021 16:00 and was scheduled for follow up on 18May2021.; Sender's Comments: Based on the temporal relationship, the association between the event acute pancreatitis with BNT162b2 can not be completely excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
8/30/2022,  12/9/2022,  11/20/2022,  2/22/2023  -- RECURRENCE OF SAME SYMPTOMS  ACUTE DVT OF RIGHT LEG, UNSPECIFIED VEIN HYPOTENSION
TIRED; This spontaneous report received from a patient via a company representative concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of tired was not reported. This report was non-serious.
Cough, weakness, SOB, pneumonia, whit thick sputum, severe fatigue.
This case was reported by a nurse via call center representative and described the occurrence of intussusception in a 2-month-old unk patient who received ROTARIX. On 4th May 2015, the patient received ROTARIX. On an unknown date, less than a month after receiving ROTARIX, the patient experienced intussusception (serious criteria hospitalization and GSK medically significant), blood in stool (serious criteria hospitalization and GSK medically significant) and vomiting projectile (serious criteria hospitalization). On an unknown date, the outcome of the intussusception, blood in stool and vomiting projectile were unknown. It was unknown if the reporter considered the intussusception, blood in stool and vomiting projectile to be related to ROTARIX. Additional details provided as follows: The reporting nurse stated that she has completed and filed VAERS form already, and would fax the report to GSK product safety. The patient did not required surgery. The nurse did not have a VAERS case number at time of report.
After having immunization on 3/25/2021, began feeling weak with low grade fever (99.9) after feeling like that for a day, daughter (nurse) noticed drawing of facial muscles and weakness to left side. took her to local hospital where they then transferred her to another hospital where they admitted her and performed a CT of brain which was positive for a stroke. Patients daughter states patient continued to run low grade temp until yesterday and is being discharged today
Patient noticed swelling of right upper arm on 3/5/14 at 5:30 pm and became worse by 3/6/14 at 7:00am, swelling, redness, itching, and mild pain at injection site stayed the same throughout the day. pt rates pain 2/10. Pt has felt relief with ice and ibuprofen. Induration measures at 6.25 in by 6 in. Pt informed to take BENADRYL 25 mg every 6-8 hrs as need for itching at 3/6/14 5:00pm.
Pt developed hives on bilateral armpits and trunk about 90 minutes post vaccine.  Pt returned to clinic and was evaluated by Provider, DNP, and given 4mg Decadron IM and a script for oral Prednisone.  Pt left clinic but then returned an hour later with worsening hives and "fullness" in the throat.  Pt was escorted to Emergency Department where pt was given 3mg Epi subq and 50mg Benadryl im.
Pt recvd MMR vax 730PM w/immediate rxn of redness (6" diam) & hives @ inject site; DPH given by mouth; observed in office x 1 1/2 hr; c/o sore throat & "upset stomach";
3/12 1 am began to have worsening headache diffuse joint pain pain in ribs Began aggressive management with Tylenol and Motrin.  Every four to six  hours.  1 pm no benefit with Tylenol or Motrin for headache began to feel nauseated took imitrex. Joint pain worsening neck pain worsening  diffuse sweating no fever7 pm an additional imitrex taken  12 am on 3/13 noted to have rash on arms joint pain unrelenting headache 50 mg imitrex taken.   8 am diarrhea rash lessening to arms joint pain still persistent excedrin  12 pm epson salt bath tried ibuprofen  Also note this was day three of menstrual cycle. Usually last 5-6 days but bleeding was so heavy changing super tampon every 2 hours for 8 hours noted clots  6 pm Tylenol pm unable to sleep joint pain lessening rash subsided   3/14 2 am joint pain has stopped night sweats Still with headache.   8 am persistent headache. Excedrin taken   1pm additional imitrex taken   5pm symptoms seemed to have self resolved.
This spontaneous report as received from a Licensed Practical Nurse refers to a patient of 4 years old child patient and unknown gender. On 09-SEP-2014 the patient was vaccinated with PROQUAD (Merck) (lot # K006771, expiration date 07-NOV-2015) (dose, route not reported). No adverse effect was reported. The outcome of events reported was unknown. No product quality complaint was involved. The reporter also stated that as of 29-AUG-2014 they had 18 doses left of this lot number. This is one of several reports received from the same source. Additional information has been requested.
the patients tested positive with Covid.; the patients tested positive with Covid.; pregnant patient; This is a spontaneous report received from a contactable reporter(s) (Other HCP) for a Pfizer sponsored program.  A female patient (pregnant) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "the patients tested positive with Covid."; MATERNAL EXPOSURE DURING PREGNANCY (non-serious), outcome "unknown", described as "pregnant patient". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive. Clinical course: Pregnant patient is in the office asking for a booster dose. The caller mentioned that the patients tested positive with Covid.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: A contributory role of BNT162B2 to event the patients tested positive with Covid cannot be excluded based on temporal association and available information.
Patient stated that she developed some hives on her neck after receiving the vaccine and about 2 weeks after vaccination began having stomach upset that she is still experiencing
I had no pain at injection spot but  I did have a severe headache shortly after injection and had to lay down at home and was in pain for six hours. I also experienced fatigue. I got out of bed in the evening and ate dinner. Then I returned to bed due to fatigue and severe nerve pain, joint pain, and all-over body pain. The second day I still felt lousy. The third day I felt OK.
ringing in the ears; This case was reported by a pharmacist via call center representative and described the occurrence of ringing in ears in a 59-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 525NP, expiry date 4th September 2021) for prophylaxis.   On 22nd October 2019, the patient received Boostrix .5 ml. On 22nd October 2019, less than a day after receiving Boostrix, the patient experienced ringing in ears. On an unknown date, the outcome of the ringing in ears was not recovered/not resolved.   It was unknown if the reporter considered the ringing in ears to be related to Boostrix.  Additional information received were as follows: In the morning, the patient received a dose of Boostrix in an unknown arm and developed ringing in the ears sometime after receiving the vaccine.
Patient has Autism.  Shortly after shot he began acting different & this was noticed by school, family & friends.   Almost a month afterwards, despite seeming much happier & outgoing, he committed suicide.
Major rash - neck, back, chest, stomach, some on thighs, left eyelid, major itching - saw doctor - took Benadryl at night and Zyrtec during day.  Been 3 weeks and still have signs of rash and some minor itching.
This spontaneous case, initially received from other health professional (Nurse) on 18-Dec-2017, concerning a 37-year-old, adult female patient. The patient's medical and medication history was not reported. On 18-Dec-2017, the patient was inadvertently administered with FLUCELVAX QIV (dose: 0.1 ml, route of administration: intradermal, batch no: 195128, expiry date: 30-Apr-2018 and anatomical location: not reported). It was reported that the nurse meant to administer PPD (purified protein derivative) instead of FLUCELVAX. On the same day, the patient developed mild redness at the site of injection. The patient recovered from the event mild redness at the sire of injection on 18-Dec-2017. The reporter assessed the events as non-serious. Non-significant case correction was received on 18-Dec-2017: Narrative was corrected.
Presyncope shortly after injection, Dizziness x 3 days, Feeling faint x 3 days.
Shot administered in right shoulder area... Adverse events include:   Extreme fatigue lasting more than 2 days (starting day after), red spots on skin across body (started after 5 days), pain in shoulder and muscles lasting more than 7 days (started day after). All events continue to this day (More than 1 week after vaccine)
I hemorrhaged for a month and had to ultimately get a D&C to stop the bleeding, despite also taking progesterone and ibuprofen to stem the flow. Nothing worked except the operation
Child regressed in language skills and other skills. no language or words spoken after few hours of vaccine.
Threads of blood discharge during urination; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6201) via an unspecified route of administration in the arm left on 03Apr2021 at 10:30 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. Concomitant medication was not reported. 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 vaccination. On 04Apr2021 at 13:00, the patient experienced threads of blood discharge during urination. It was unknown whether the patient received any treatment for the event. The clinical outcome of the event threads of blood discharge during urination was unknown.  No follow-up attempts are needed. No further information is expected.
I awoke to severe abdominal pains. I tried to ignore them but they became stronger. So, I stood up, took about five steps toward my living room.  The pain then shot from my abdominal area up into my head. I gasped for air and couldn't breathe. I became dizzy and then everything went black.  I came to due to the sound of my friend's voice yelling my day.  I opened my eyes and realized that I was spread out on my bedroom floor; and that I had fainted.  I got up and felt light headed and out of it.
swelling; redness; itchy; pain; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (swelling), ERYTHEMA (redness), PRURITUS (itchy) and PAIN (pain) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-May-2021, the patient experienced SWELLING (swelling), ERYTHEMA (redness), PRURITUS (itchy) and PAIN (pain). At the time of the report, SWELLING (swelling), ERYTHEMA (redness), PRURITUS (itchy) and PAIN (pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.  No concomitant medications reported.  Treatment information was not reported.
10 minutes after receiving the first dose, extreme dizziness, light-headedness, nauseous, and fast heart rate. Lasted about one minute. No side effects after that.   Two days later, had a sudden vasovagal reaction and was extremely nauseous. On the third day, spent the morning vomiting, about 4 times.  Was fine by the afternoon. No chills, fever, or shakes. No muscle soreness either.
Stiffness in both legs; Achiness in both legs; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Stiffness in both legs) and PAIN IN EXTREMITY (Achiness in both legs) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 091D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Oct-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (Stiffness in both legs) and PAIN IN EXTREMITY (Achiness in both legs). At the time of the report, MUSCULOSKELETAL STIFFNESS (Stiffness in both legs) and PAIN IN EXTREMITY (Achiness in both legs) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient was taking other medications. No treatment medications were reported.
On  1/7/2021, I woke up around 0600. I took Allegra and Sudafed. At 0700,  I got the shot; waited 30 min; felt fine and left.  At 0745, I started itching and developing a headache (on my drive home).  At 0800, restricted breathing; took 50 mg of Benadryl (resolved) and 1000mg acetaminophen for headache (unresolved).  At 1200, 99.6 F temp with unresolved headache and felt nausea; took 4mg Zofran.  At 1300,  took 1000mg acetaminophen; temp was 101 F and stomach felt upset so I didn't want to take ibuprofen At 1900, took 1000mg acetaminophen, temp 100.2F; tried to have some soup; my stomach upset and hurts and feels worse with food At 2200, tempt 99.8 F; stomach hurts; achy; itchy; took 600 mg ibuprofen and 50 mg Benadryl
At injection site of left deltoid, an oval shaped area (23 mm x 13 mm) dark pink to pale red area. No swelling, heat, drainage noted. Denies discomfort or itching.
Day 1-2 after injection pt reported injection site pain and fever. Days 2-6, arm pain, and chills
patient felt throat constriction and difficulty breathing <5 minutes after vaccine administration.  Epi pen was used and patient felt immediate relief; EMS called, patient was transported to ED.
Exactly 1 week later I woke up with head and lung congestion, chills ,  slight headache,  sneezing, coughing and a fever  of 100.7 very tired and congested.
Nausea; Headache; Vomiting; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: EN6203), via an unspecified route of administration in the left arm on 10Mar2021 at 11:00 (at the age of 47-year-old) as a single dose for COVID-19 immunisation. The patients medical history included iron deficient anemia, anxiety, panic attacks, and vertical gastric sleeve surgery in 2015. The patients past drug history included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: EL3247), via an unspecified route of administration in the left arm on 19Feb2021 at 11:00 hours, as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19 and did not receive any other vaccines within four weeks prior to the vaccination. The patient had not been tested for COVID-19, since the vaccination. The concomitant medications included multivitamin (MANUFACTURER UNKNOWN), iron supplement (MANUFACTURER UNKNOWN), from unknown dates and unknown if ongoing. On 12Mar2021, two days after the second vaccination, the patient experienced nausea, headache and vomiting after taking multivitamin and iron supplements. No therapeutic measures were taken for these events. The clinical outcome of nausea, headache and vomiting was recovered.  No follow-up attempts are needed. No further information is expected.
Information has been received from a  pharmacist concerning an adult hospital employee who was vaccinated SC with 0.5mL first dose of varicella virus vaccine live. The reporter indicated that the pt experienced a rash following vaccination. The reporter learned of the rash through a written question posed to her by the nursing staff asking if the pt should receive a second dose. The reporter did not have any description of the rash, whether it was improving, any other pt information or contact information for the employee health service. It was also noted that it was unknown if the pt was pregnant. Unspecified medical attention was sought and no treatment or prescription drug was required.  A product quality complaint was not involved. Additional information was received from the pharmacist which indicated that she did not have any follow up information but she would contact the director of employee health for further information. Additional information has been requested.
The patient called the Dept of Health Services for guidance on the adverse event.  She plans to self report to VAERS soon.  She is in good health, and has some experience in the medical field, having worked in the past at a county health department.  On Oct 29, 2008 she received a routine Tdap since it was > 10 years since her last Td.  The site hurt and she felt feverish.  The next day her elbows, knees, and ankles were very sore, and remained quite painful the second day.  She had no rash at the time, nor did she have joint swelling.  The pain decreased to a tolerable level on the 3rd and 4th day, but "achiness" in her elbows, knees, and ankles has persisted since. She has been checked for "arthritis" and was told that she did not have arthritis.  She called to find out if her persistent symptoms could be due to the Tdap vaccine.  She had previously had a "severe" reaction to an MMR 14 years ago and was told not to ever have another MMR.  My assessment (as medical officer for the Immunization Office Program) was that it could be due to a type of serum sickness reaction to Tdap, more likely due to the tetanus (or diphtheria) component, since serum sickness after repeated Td has been previously reported.  I recommended that she directly make a report to VAERS.
Aches, fever, sweating, tightness in chest, flu like symptoms, significant rapid weight gain
Day after vaccine-patient developed red itchy swollen arm (same arm as injection). Continued to grow to larger area in next few days. Not painful goes from elbow to halfway up arm and about 6" diameter. Not overlapping injection site.
Headache Muscle and joint aches fatigue Jan 21 2021 until present Feb. 5. Doctor visit Feb 4
Administered vials that were exposed to room temperature for more than 12 hours; A spontaneous report (United States) was received from an employee and a physician concerning a patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and was administered with product that was exposed to room temperature for more than twelve hours.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 04 Jan 2021, a freezer containing a vial of mRNA-1273 failed.  At 1:11 A.M. the vial experienced a temperature excursion, exceeding 8 degrees Celsius. Over time the dose thawed and reached room temperature.  On 04 Jan 2021, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection and was administered with product that was exposed to room temperature for more than twelve hours.  No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.   The event, administered with product that was exposed to room  temperature for more than twelve hours, was resolved on 04 Jan 2021.; Reporter's Comments: This case concerns a patient of unknown gender and age who received their first of two planned doses of mRNA-1273 (Lot unknown), reporting Product that was exposed to room temperature for more than twelve hours without any associated adverse events.