chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Yesterday on my right hand arm, this started on right in my arm and then under the armpit it's like a swelling over there, big swelling, very big, it's like, it's paining a lot; Yesterday on my right hand arm, this started on right in my arm and then under the armpit it's like a swelling over there, big swelling, very big, it's like, it's paining a lot; it's paining a lot; I had a high fever yesterday; This is a spontaneous report from a contactable consumer (patient). A 36-years-old male patient received first dose of BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number and Expiration date was Unknown) via an unspecified route of administration in right arm on 16Apr2021 as dose 1, single (at the age of 36-years-old) for COVID-19 immunization. Patient does not have any other medical condition and there were no concomitant medications. On 17Apr2021 (reported as yesterday, at the time of report), the patient experienced on his right-hand arm (vaccinated arm), this started on his right arm and then under the armpit it's like a swelling over there, big swelling, very big, it's like, it's paining a lot and he also had a high fever. The patient underwent lab tests and procedures which included body temperature resulted high (fever) on 17Apr2021. The seriousness for the events unspecified. No investigation assessment reported. Therapeutic measures were taken for a high fever included Tylenol 2 tablet at a dose of 620 mg (unclear, it is written on the bottle take 2 tablets for adult) in the morning time like around 11:30 and then after 8 hours and then he had taken after having his dinner after 21:00 yesterday evening time (on 17Apr2021). Patient believes it is a very big side effect that he was facing under the armpit was swelling. The clinical outcome of all events was not recovered (still persisting), at the time of report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
chills; fever; nausea; vomiting; headache; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 13Apr2022 at 10:00 as dose 1, single (Batch/Lot number: unknown) at the age of 67 years for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: penicillin" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: CHILLS (non-serious) with onset 13Apr2022 at 18:00, outcome "recovering"; PYREXIA (non-serious) with onset 13Apr2022 at 18:00, outcome "recovering", described as "fever"; HEADACHE (non-serious) with onset 13Apr2022 at 18:00, outcome "recovering"; NAUSEA (non-serious) with onset 13Apr2022 at 18:00, outcome "recovering"; VOMITING (non-serious) with onset 13Apr2022 at 18:00, outcome "recovering". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of chills, pyrexia, nausea, vomiting, headache.  Additional information: No other vaccine in four weeks. Other medications in two weeks included inhalers. No covid prior vaccination. No covid tested post vaccination.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Incredible fever/chills and body aches that are greater than what any prior virus has ever felt like.  Temperature cannot be controlled with Tylenol or ibuprofen and is staying above 103 despite all efforts.
Vaccinated 11/1/11 that evening noticed soreness shoulder to elbow and "started to puff". Continued with swelling and redness and heat throughout the week, starting to taper off on Saturday. Itchiness at red area on inside of forearm. Bruise at injection site half dollar size, and noticed another bruise half dollar size 6 inches down on outside forearm. No fever but warmness at site.
vomiting started 315PM 2JUN93 was spit-up 1 times since then; has kept down 2oz formula since 315PM yesterday; t99.0 today; mom states has colic & usually spits up p/feeding;
Patient very hot, but has no fever. Patient stated has never had trouble before with the flu shot. Patient stated that his throat closed a little and was taking Benadryl. On pain medications for his arthritis, but do not have the name of the medication. Patient was informed to see his Dr. if it got any worse. Office spoke with the patient on 11/5/010 and the patient stated that he felt alittle drowsy and stuffed up.
Redness, induration, itching, discomfort. Seen 5/16/13 for increasing size up to 5.5 cm, warmth, tenderness, redness induration, itching- placed on Benadryl cream and hydrocortisone cream and oral prednisone 20mg BID x 5days.
Pt administered pediatric (5-11) dose of  0.2ml instead of adult booster dose 0.3ml.  Pt informed of error.  She returned to  Center within a couple of hours and rec'd correct adult formulation Booster dose 0.3ml.
Arm hurt from shoulder to elbow - had chills, next day had welts on arm and hives and itchy.
the patient did not experience any symptoms; improperly stored Varivax or Proquad; This non-valid spontaneous report as received from a medial assistant refers to multiple patients of an unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical history provided.  On an unknown date (reported as on multiple dates between 14-SEP-2019, and 15-NOV-2019), the patients were vaccinated for prophylaxis with improperly stored doses of varicella virus vaccine live (oka/merck) (VARIVAX) lot # S011952, expiration date 16-APR-2021, or with lot # S012037, expiration date 17-APR-2021, or with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) lot # S003865, expiration date 08-AUG-2020, or with lot # S021617, expiration date 09-JAN-2021 (strength, frequency, route of administration and anatomical location were not provided in neither of vaccines). All of vaccines were reconstituted with a properly stored sterile diluent. The vaccines were exposed to temperature of -10 degrees Celcius (frame: from -14 degrees Celcius to -10 degrees Celcius) for 1 hour and 45 minutes, and -7.1 degrees Celcius for 30 minutes (frame: -9 degrees Celcius to 8 degrees Celcius). There was also a previous temperature excursion of -11.6 degrees Celcius for 7 hours and 10 minutes (frame: from -14 degrees Celcius to -10 degrees Celcius). The digital data logger was involved. The patients did not experience any symptoms.
Child was given vaccine and had three days of inconsolable crying along with inability to walk for two days.
Patient started with pain in arm 3-4 days post vaccination.  It then progressively worsened.  It was determined that she had a blood clot that caused swelling resulting in nerve pain and numbness.  Patient currently being treated for blood clot and receiving PT for the nerve damage.
Rash on right cheek, itchy, raised, deep red, uncomfortable followed in a few days by nerve pain. After taking a steroid and anti- viral drug for 1 week, the inflammation decreased and it was no longer uncomfortable. The nerve pain is now gone as of 6/3, and my rash is much small and no longer itches.
Subsequent to receiving vax the pt came to office complaining of arthralgia. Pt states that 1 week post vax, she began to have some hard masses around her ears, then developed throughout the next couple of days some aches and pains in her knees and hands, along with swelling. Pt denies rash.
Right thigh, raised circular lesion 1.5 cm warm to touch, mildly tender; 3 vesicles of differing sizes within the lesion.
On April 8, I fainted shortly after getting out of bed around 8:30 AM EST. Despite increasing my hydration and ensuring I was eating adequately, I've felt dizzy and off-balance since then to now (April 9 2:00 PM EST).   I also had "moderna" arm a week after the shot where I had a rash/splotch at the site of the injection. I could feel a bump on Friday, April 9 and then the splotch grew over April 3-5. It then started to fade and is almost gone.
Vaccines administered 4/23/03 (DTaP and IPV adjacent in left upper thigh). By 4/24 AM developed 2.5" firm, red, itchy lesion next to site of injections. Afebrile.
Information has been received from a physician concerning a 13 year old (also reported as 12 year old) female who was vaccinated with two doses of MMR II on 21-JUL-1997 and 28-JUL-2000, respectively. On 17-JAN-2010 the patient developed mumps on the right side. On 18-JAN-2010, the patient was diagnosed with parotitis. Lab test was performed on the same day (result not provided). This is one of several reports received from the same source. No further information is available.
I am fully vaccinated and 11-13 days after each initial shot, i have a rash on my chest, breast, arms (upper), my foot, my stomach. I has a biopsy done and was told i had a hyper sensitive reaction to a bug bite. i was told to check for bed bugs. I have had 2 pest control techs and a bed bug sniffing dog at my home , no bed bugs.....  My general doctors said it could be a reaction, my dermatologist said now what no how is this from the vaccine.!  I have been breaking out for almost a month and a half now. I fully believe this is from the vaccine and want to report it is as such.  My doctor said first it may be Shingle and started treating  it like that. i was not not shingles, however the rash does look similar to that as well as chicken pox and hives.
exposed down to 28 F, administered; This case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   Additional Information: GSK Receipt Date: 29-SEP-2022 Reporter's Comment: The registered pharmacist reported that the patient received a dose of Shingrix vaccine, and which was exposed down to 28 Fahrenheit for 8 hours. The reporter stated that there were no prior excursions. The reporter asked about Shingrix stability and wanted to know any recommendation on revaccination. The reporter was unable to provide any vaccine or patient details at this moment. The reporter did not consent to follow up. Additional supportive information: The patient received a dose of Shingrix vaccine, and which was exposed down to 28 Fahrenheit for 8 hours, which led to incorrect storage of drug. This case was one of 8 cases reported by same reporter.; Sender's Comments:  US-GSK-US2022140239:Same reporter US-GSK-US2022140237:Same reporter US-GSK-US2022140235:Same reporter US-GSK-US2022140236:Same reporter US-GSK-US2022140241:Same reporter US-GSK-US2022140234:Same reporter US-GSK-US2022140227:Same reporter
patient having generalized joint pains and fatigue 3 weeks out Started a day after receiving vaccine, feels only 50% back to normal.
Urticarial rash distal to injection site x 2 yrs in a row.
Fever after shots - continue Tylenol PRN, RTC if s/s continue.
2 hours after flu-shot - left deltoid - c/o itching skin, no fever, no oral c/o.
Very dizzy and unfocused.  Headache, poor eyesight, head pressure, inability to concentrate
difficulty, swallowing  and breathing.  Rapid heart beat, tingling in the throat and cheeks
Possibly given compromised vaccine ( vaccine reconstituted and administered with sterile water instead of manufacturer's diluent). No reported adverse health events by patient at this time. Patient has been contacted by staff and told to return to Immunizations clinic during appointment.  *Item 5 was filled due to form requirement but it is unknown if patient has experienced an adverse health event. This VAERS form is being filled out for documentation and education purposes.   Revaccination determined by local medical team with advice from the medical professional.
The patient received his first dose of Pfizer. Around 13 minutes after receiving the vaccination he started complaining of itching and pain on his left arm, which was the arm the vaccine was administered in. The patient also said his neck itched. The patient was given 50 mg of Benadryl (he was 144 lbs). I went over the signs of anaphylaxis with his mom. The patient was autistic and at one point indicated that his throat felt weird. The mom and I got him to explain what he felt and that is when he told us he had a weird taste in his mouth but was breathing fine. We gave the patient some water and he stayed for observation for another 20 minutes and he said he felt better and they left. I called the mom this evening at 7pm to check on him and she said he was fine.
102+ degree fever Chills  Body aches  Nausea  Vomiting   From 15 hours after vaccine to 36 hours after second dose  Also now I have a uti which may or not be related to vaccine
approx 3-4 hrs p/vax pt awoke from nap w/high pitched, inconsolable crying lasted 1 hr;
Pain and swelling at the injection site for about 4 days, painful and slightly swollen lymph nodes in the left armpit, painful armpit when arm is pressed against the body (lasting about 7 days). Body temperature around 37.4°C lasting 32 hours starting several hours after getting the shot (usual body temperature 36.4°C). Chills and body aches lasting 24 hours.
syncope and fall.  also had myalgia and low grade fever. got up middle night to go bathroom.  syncope and LOC. fell and hit corner head. needed 7 stitches
09:30 AM Vaccination site started swelling and burning. 10:00 AM Dyspnea, chest tightness, Skin-pale, cold, and clammy 11:00 AM - Treatment with diphenhydramine IM, epipen IM, and albuterol inhaler 11:20 AM - symptoms began to resolve
Information has been received from a nurse concerning a 25 year old female with penicillin allergy who on 30-SEP-2008 was vaccinated with her first dose of GARDASIL and her second dose of the vaccine was on 11-DEC-2008 and her third dose of GARDASIL on 24-MAR-2009 (0.5 ml IM, 661846/1312X). The same day of the 3rd vaccination, the patient called the office back because she developed redness and itching from the elbow to the shoulder in the injection arm. She also developed lightheadedness. No additional information was available. Additional information has been requested.
Muscle and joint pain in the right arm; Muscle and joint pain in the right arm from the elbow to the shoulder felt; limited range of motion in arm in all directions; the muscle was being twisted very sore/painful to touch/ arm was tender after injection; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EL9266), via an unspecified route of administration in arm right on 04Feb2021 at 16:00 (at the age of 68-year-old) as a dose 1, single for COVID-19 immunization. The patient's medical history was not reported. The patient's concomitant medication in two weeks included vitamin d [vitamin d nos] and multi vitamins. Other vaccine in four weeks was reported as no. No covid prior vaccination and no covid tested post vaccination. On 08Feb2021 at 17:00, the patient experienced muscle and joint pain in the right arm from the elbow to the shoulder felt as the muscle was being twisted very sore/painful to touch limited range of motion in arm in all directions arm was tender after injection and the symptoms listed above began on 08Feb2021 in the evening, did not start to lesson until 11Feb2021. Treatment was not received for the events. The outcome of the events was recovering.  Follow-up attempts completed. No further information expected.
Heart "ached"; Fatigue; Muscle pain in left arm; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Heart "ached"), FATIGUE (Fatigue) and MYALGIA (Muscle pain in left arm) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     Concomitant products included METOPROLOL, ESOMEPRAZOLE SODIUM (NEXIUM [ESOMEPRAZOLE SODIUM]) and HYDROCHLOROTHIAZIDE for an unknown indication.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CHEST PAIN (Heart "ached"), FATIGUE (Fatigue) and MYALGIA (Muscle pain in left arm). At the time of the report, CHEST PAIN (Heart "ached"), FATIGUE (Fatigue) and MYALGIA (Muscle pain in left arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.
Given vaccines, Developed rash (generalized) within 5 minutes, Benadryl administered and within 15 minutes rash had faded.
Information has been received from a physician concerning a female patient in her mid-20s with no pertinent medical history or known drug allergies who on approximately 24-JUL-2009 (two months ago) was vaccinated intramuscularly with the first 0.5 mL dose of GARDASIL (lot number not provided). There was no concomitant medication. Subsequently, the patient's hair was falling out. Therapy with GARDASIL was discontinued and the patient had not received any further doses. The patient called the physician. The result of the thyroid check was negative. The patient did not recover from the hair's falling out. Follow-up information has been received from a health professional concerning a 25 year old patient with allergies to hydrocodone and ZOFRAN who on 24-JUL-2009 was vaccinated with the first dose of GARDASIL (lot# 659054/0315Y) at 11:45. It was reported that the patient called to let them know that she had hair loss after her first injection of GARDASIL. The patient's lab work was done at other doctor's office. All of the patient's labs were normal and the patient thought the hair loss was from the shot. There was no illness at the time of vaccination. At the time of the report, the patient's status was unknown. No further information is available.
Needle defect , manufacturer vaccine administrator. I,  filled the vaccine then administered to this patient. Then was able to observe  one drop of vaccine leaking from the needle (this drop travelled down her arm). Though she received most of her 2nd dose of Moderna, I decided to file VAERS given that she received slightly less than 0.5 ml.
Home Ag (Nasal Swab): Positive; Home Ag (Nasal Swab): Positive; This is a spontaneous report received from a non-contactable reporter(s) (Nurse).  A 46-year-old female patient (unknown if pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 04Oct2022 as dose 4 (booster), single (Lot number: GJ6742) at the age of 46 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 06Feb2023, outcome "unknown" and all described as "Home Ag (Nasal Swab): Positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (06Feb2023) Positive. It was unknown if therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information : Covid test type post vaccination: Nasal Swab (Home Ag) and was positive.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: The reported COVID-19 positive after BNT162b2, BNT162b2 omi ba.4-5 immunization is considered ineffective of suspect, and the Company cannot completely exclude the possible causality between the reported events and BNT162b2, BNT162b2 omi ba.4-5 administration.,Linked Report(s) : US-PFIZER INC-202300060734 same patient different dose/drug/event;
Breakthrough case admission after 2 vaccines Moderna 9/21/21 Lot# 051E21A;  Moderna 10/19/21 Lot# 017F21A
Approx. 5 mins. following vaccination with HPV #1 vaccine (Gardasil)and Hep A#1 vaccine (Havrix) pt. had vasovagal syncope episode with short (4-5 seconds) of seizure-like jerky movements. Pt. hit forehead on piece of equipmemt in exam room which resulted in 1mm laceration that was cleaned and bandaged. Pt. became responsive in 5 seconds. Father & APN witnessed episode. The pt. was placed flat on an exam table with a cool compress and was observed for 30 minutes. After this time he was evaluated and found to be alert and responsive and was cleared to leave the clinic area with his father.
nose bleed several time four or five days after vaccine. in last 15 days nose bleeds total 7-8 time  no treatment at this time , was directed to report to gov
Approximately 3 weeks post vaccine, patient reported to his mother that for 2 weeks after receiving his vaccines he felt really tired, weak, and legs felt like rubber. He felt like he could not stand, he wanted to run but could not.
Hemoglobin levels went up; Ache after Booster Dose; Body ache after Booster Dose; Head ache after Booster Dose; After receiving the Booster, hemoglobin recount went up to 10; Immunocompromised patient given booster dose after 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of HAEMOGLOBIN INCREASED (Hemoglobin levels went up), PAIN (Ache after Booster Dose), MYALGIA (Body ache after Booster Dose), HEADACHE (Head ache after Booster Dose) and THERAPEUTIC RESPONSE UNEXPECTED (After receiving the Booster, hemoglobin recount went up to 10) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Myelodysplastic syndrome and Allergy. Concomitant products included EPOETIN ALFA (PROCRIT) for an unknown indication.    On 24-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HAEMOGLOBIN INCREASED (Hemoglobin levels went up), PAIN (Ache after Booster Dose), MYALGIA (Body ache after Booster Dose), HEADACHE (Head ache after Booster Dose), THERAPEUTIC RESPONSE UNEXPECTED (After receiving the Booster, hemoglobin recount went up to 10) and ACCIDENTAL UNDERDOSE (Immunocompromised patient given booster dose after 2nd dose). At the time of the report, HAEMOGLOBIN INCREASED (Hemoglobin levels went up), THERAPEUTIC RESPONSE UNEXPECTED (After receiving the Booster, hemoglobin recount went up to 10) and ACCIDENTAL UNDERDOSE (Immunocompromised patient given booster dose after 2nd dose) outcome was unknown and PAIN (Ache after Booster Dose), MYALGIA (Body ache after Booster Dose) and HEADACHE (Head ache after Booster Dose) had resolved.            No treatment medication were reported Patient did not experienced a similar event on the past. All the vaccines were given in her deltoid muscle. She never tested positive for Covid-19. She did not received any other vaccine within 1 month prior to Moderna's.   This case was linked to MOD-2022-504281 (Patient Link).
Pt states she felt dizzy then passed out < 5 mins. after HPV #1 given monitored H.R. cold wet towel to head juice box given. Kept pt lying down on exam bed for 20 min.
Information has been received from a physician concerning a 13 year old female who on 10-FEB-1998 and 19-JAN-2001 was vaccinated with the first and second dose of MMR II (lot # not reported) respectively. On 27-NOV-2009 the patient experienced onset of symptoms and on 29-NOV-2009 the patient was diagnosed with mumps. The patient's body temperature was 103 F and she had left side parotitis. It was noted that the left side of the patient's neck was swollen. At the time of the report, the outcome of mumps was unknown. Additional information has been requested.