chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case, initially received on 15-Aug-2018, reported by a consumer, concerning 20-year-old, adult, female patient. The patient did not have any medical history and no history of allergies or allergic reactions. The patient was not taking any concomitant medications. On 23-Aug-2016, the patient was administered FLUVIRIN Thiomersal (dose: 0.5 ml, anatomical location: deltoid (not known left/right deltoid), batch number: 1618701, expiry date: 30-Apr-2017, route of administration: not reported). On the same day, about 6 to 7 hours after vaccination, the patient developed hives all over her body. It was reported that the patient was in and out of the emergency room (ER) about three times for anaphylactic issues (dates for ER visit not reported). The event hives lasted for about 10 days. The patient went to several different doctors regarding event. The patient was unsure why she had a reaction to the vaccine. It was unknown whether the patient received treatment for the events. At the time of this report, the patient had recovered from the events (reported as about 10 days after injection). The reporter considered the case as serious (medically significant). Update received on 19-Oct-2018: Non-significant case correction (IRD: 15-Aug-2018): The batch number was corrected from '161870' to '1618701' in product tab. The narrative was amended accordingly.
Client received his vaccine and during his 15-minute monitoring period, he passed out.  He received immediate follow up care by an RN onsite who took his vitals--pulse low (40bpm and 42bpm respectively at 9:41 am and 9:45 am). His blood pressure was 88/48 at 9:48 am. 911 was called immediately. They arrived within five minutes. They treated him but determined he did not need to be taken to a hospital. They took his glucose which was 87.  His vitals were stable by the time they made the decision to leave. They told him to continue sitting and monitoring for 15 minutes and have someone assist him in walking around some. Once he felt good to leave, he would be allowed to go home. A volunteer walked this gentleman out to his car when he felt well and was ready to leave. Client had no injuries from his fall.
Booster; Fever; chills; lethargy; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non-HCP).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1; MANUFACTURER UNKNOWN), for COVID-19 Immunisation; Covid-19 vaccine (Dose 2; MANUFACTURER UNKNOWN), for COVID-19 Immunisation. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "Booster"; PYREXIA (non-serious), outcome "unknown", described as "Fever"; CHILLS (non-serious), outcome "unknown", described as "chills"; LETHARGY (non-serious), outcome "unknown", described as "lethargy". Additional information: A non-contactable consumer communicated to a Pfizer sales representative for a patient. Patient had fever, chills, lethargy within 10 hours of Pfizer Covid vaccine third dose. Event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report as received from a female physician of unknown age refers to herself. The patient's relevant medical history and concomitant medications were not reported. On an unknown date in approximately 2009 (reported as about six years ago), the patient was vaccinated with a pediatric dose of VAQTA 25/0.5 (units not provided) (lot number, expiration date, dose and route not reported) and the patient was 19 years of age or older at that time). No adverse effect was reported. This is one of several reports received from the same reporter. Additional information is not expected as the reporter declined to provide any additional information.
Date and time of vaccination: (list both if they received both shots):  1/6/2021 (First dose) 1/27/2021 (second dose) redness, swelling at injection site, feels like fat hanging from the arm. still occuring
Throat swelling; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PHARYNGEAL SWELLING (Throat swelling) and HEADACHE (Headache) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On Apr-1942, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PHARYNGEAL SWELLING (Throat swelling) and HEADACHE (Headache). At the time of the report, PHARYNGEAL SWELLING (Throat swelling) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
injection site warm to touch; injection site itchy; injection site red; injection site sore to touch; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (injection site red), VACCINATION SITE PRURITUS (injection site itchy), VACCINATION SITE WARMTH (injection site warm to touch) and VACCINATION SITE PAIN (injection site sore to touch) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Apr-2021, the patient experienced VACCINATION SITE ERYTHEMA (injection site red), VACCINATION SITE PRURITUS (injection site itchy), VACCINATION SITE WARMTH (injection site warm to touch) and VACCINATION SITE PAIN (injection site sore to touch). On 05-Apr-2021, VACCINATION SITE PRURITUS (injection site itchy), VACCINATION SITE WARMTH (injection site warm to touch) and VACCINATION SITE PAIN (injection site sore to touch) had resolved. At the time of the report, VACCINATION SITE ERYTHEMA (injection site red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported. The treatment information was unknown.
Developed a reaction in the back of her left arm about the circumference of a pool ball. It was red, raised, hot to the touch, and tender. Dr told her to take Benadryl 25mg po every 6 hours (4 taken). Sat 07/19/14 reports lump doubled in size, painful adn hot. MD started her on Cephalexin 500mg BID which was started 7/20/14 AM. Ibuprofen and cold packs used for comfort. Low grade fever 7/19 of 99.3 x 24 hours. As of July 21, 2014, size had not decreased, warm to touch and tender, no fever.
Admitted to hospice care on 05/11/2021 with an admitting diagnoses of Mantle Cell Carcinoma. Date of death 05/17/2021
One week later after vaccine I noticed I had a swollen lymph node on my clavicle on  my left side. I seen my doctor he said they think it was a lymph node he said just to watch it. Until now its still the same,
High skin pain or nerve pain on my right torso which is the  same area where I had SHINGLES about 35 years ago.  There is nothing to see on my skin. It looks normal.  I am taking both Motrin and Extra Strength Tylenol which does very little to ease my skin pain.  I have off and on  strong skin pain like a pin sticking into my skin when sitting still and skin surface pain when my shirt rubs onto my skin.
veins in the hand and wrist (in the arm with the shot) started hurting a lot and they were like bigger for 30 minutes; veins in the hand and wrist (in the arm with the shot) started hurting a lot and they were like bigger for 30 minutes; This is a spontaneous report received from a contactable consumer, the patient. A 44-year-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration on 21Mar2021 (at the age of 44-years) as a single dose for COVID-19 immunisation. Medical history included high blood pressure. The patient was not allergic to medications, food, or other products. Concomitant medication included amlodipine (MANUFACTURER UNKNOWN). The patient previously received unknown dose unspecified Pfizer vaccine via an unspecified route of administration on an unspecified date for immunization. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 21Mar2021 at 16:00, the patients veins in the hand and wrist (in the arm with the shot) started hurting a lot and they were like bigger for 30 minutes. The patient did not receive any treatment for these events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events veins in the hand and wrist (in the arm with the shot) started hurting a lot and they were like bigger for 30 minutes was recovered on 21Mar2021.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.  Amendment: This follow-up report is being submitted to amend previously reported information: Vaccination Facility Country captured ; patient's information was captured; for relevant med history#1, the verbatim was updated as High blood pressure; final sentence updated; dose number leave blank, dose description captured as DOSE NUMBER UNKNOWN, SINGLE; historical vaccine was deleted; narrative updated and start date and stop date of SD updated.
3 days after 2nd shot of Moderna  COVID-19 vaccine, I was having  bad vertigo that needed bed rest and assistantance for basic needs such as had shower or even just walked. Vertigo and ear ringing/tinnitus remains and getting worse for 3around 3 days. Vertigo and dizziness had  disappeared after 2 week, but nausea were sometimes on off for about 3 weeks. Tinnitus/ ear ringing (sometimes along with feel like banging in my left ear) still presents until today (over a year).
Received vaccine Thursday at 1:23 pm. Friday at 10:30 am started getting chills and body aches. Throughout the day body aches continued to get worse and nausea began around 2:30 pm and continued all night. No appetite, and only slept 3.5 hours then awoke and began to throw up for several hours. (mostly dry heaving due to not being able to eat) Saturday all day was heavy and sore eyes, headache, nausea, sore throat but the body aches were getting better. Saturday at 8:23 pm still feeling nausea with a sore throat and very tired... To Be Continued
Received the 2nd Moderna vax on 3/12/2021.  By the following evening  I had  a fever of 100F and pronounced dizziness.  I had to move through the house slowly grabbing furniture the tops of and door frames for stability.   The fever dropped to normal over of the course of a week.  As of 5/2/2021, the dizziness has diminished perhaps 25%.
This spontaneous report as received from a pharmacist referring to a 2 (of initially reported 3) patients of unknown age and gender with no pertinent medical history reported. On an unknown date these two patients were vaccinated with ZOSTAVAX (lot number and expiration date could be not provided) (dose and route not provided). The patients were not on other suspect therapies or concomitant medications at the time of the injection. On an unknown date the patients experienced large rashes in diameter, swollen and warm to touch, kind of look liked cellulitis, described as a "swollen area in their arm in the size and diameter of a softball". The pharmacist reported that these two patients did not received treatment of any kind and the swollen area resolved within ten days on its own. It was also reported that another of the initially reported patients received treatment for cellulitis (MARRS1306USA005637). Additional information has been requested.
Patient reported a 3 x 5 inch very swollen red area about 2 inches below the injection site which is self-resolving. She reported that it is almost back to normal. She felt "kind of icky" for a few days, which I explained is a normal side effect.
Headache, Myalgia, Fever, fatigue, chills, loss of appetite Narrative:  Employee reports symptoms resolved in 48 hours, only used home tylenol for treatment
Shingles after Shingrix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of shingles in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, immediately after receiving Shingrix, the patient experienced shingles (Verbatim: Shingles after Shingrix). The outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.     It was unknown if the company considered the shingles to be related to Shingrix.   Additional Information: GSK Receipt Date: 31-JUL-2023 The reporter was questioning the efficacy of Shingrix as the patient returned to him with shingles shortly after receiving the Shingrix vaccination. The reporter consented to follow up. This case is linked with US2023AMR107644, by same reporter.; Sender's Comments:  US-GSK-US2023AMR107644:Same reporter, same product, different patients.
Received Td and Pneumococcal Poly. on 9-3-03. Developed baseball sized, localized bump at injection site of LEFT arm. By next am., entire arm was hot and swollen, had headache, nausea, and fever. Intructed by ER to take benadryl and advil. Now swelling is decreasing and client feels better, no fever, headache or nausea.
I got the 2 vaccines and still ended up with a bad case of Shingles/ Suspected vaccination failure; Ended up with a bad case of Shingles; Now I have nerve damage; A lot of / pain; A lot of itching; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a 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), shingles, nerve damage, post herpetic neuralgia and pruritus. On an unknown date, the outcome of the vaccination failure and shingles were unknown and the outcome of the nerve damage, post herpetic neuralgia and pruritus were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, nerve damage, post herpetic neuralgia and pruritus to be related to Shingles vaccine and Shingles vaccine.  Additional details were reported as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient received 2 shingles vaccines and still ended up with a bad case of Shingles and at the time of reporting, the patient had nerve damage with a lot of itching and pain. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.
Headache; Chills; This is a spontaneous report from a contactable healthcare professional (patient). A 48-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EN5318; Expiration date was not reported), intramuscularly on the right arm on 26Jan2021 (10:00) at a single dose for COVID-19 immunization at the hospital. The patient's medical history was not reported. Concomitant medications included omeprazole, metoprolol, methocarbamol, vitamin D3, pregabalin and levothyroxine. The patient had previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EK5730; Expiration date was not reported), intramuscularly on the right arm on 05Jan2021 (when the patient was 48 years old) for COVID-19 immunization, and had chills, headache, sore throat, nausea and loss of smell. The patient was not pregnant at the time of vaccination. In Jan2021, after the second dose of vaccination, the patient had headache and chills. The patient had resulted to going to the doctor/clinic visit due to the events. The patient did not receive any treatment for the events. The outcome of the events, headache and chills, was recovering. The patient was not diagnosed with COVID-19 prior to the vaccination, and had been tested post-vaccination. The patient's nasal swab test was negative on 11Jan2021.
Had vaccine on 5/17/18 at 12:40 and started not feeling herself around 6:00 pm. Dad states had fever under arm 100 degrees c/o not wanting to walk and leg hurting where she got her shots. C/o right leg swollen with pain and walks with limp. Also c/o no appetite but is drinking fluids.
We are reporting that the patient became pregnant after receiving 1st dose of Gardasil. Her last menstrual period was 1/17/07. She reported pregnancy to us on 3/1/07. Her EDC is 10/24/07.  She received Gardasil on 1/16/07.  Follow-up - Adverse event onset 01/16/2007 at 15:30 PM.
Pt reported severe dizziness.  Also reported HTN but not compliant with medications. In fact he has "not taken it since yesterday".  EMS attended pt.  VS were consistent throughout as noted.  Pt continues to report dizziness.  At 3:07 PM pt requested to go to hospital for new onset "involuntary  neck movements"  These reported neck movements were unobservable by this nurse and multiple staff.  Pt walked to elevator with fire/EMS to wait for ambulance to arrive for transport.  Pt left floor under own volition with no observable signs of distress.
Rash in various areas of body, itching and redness. Grew progressively worse.
Itchy red rash developed around vaccine site  five days after vaccine; c. 4 in. diameter  Also, fever and redness and soreness at vaccine site 1-2 days after vaccine
4 pm headache 6 pm Stomach ache 10 pm through 6 am vomiting and diarrhea  Fatigue and headache continuing, 3 pm
eye pain beginning two days after shot on both 5/19 and 6/9 dull headache low energy that did not go away- cold sweats with mild fever for 24 hours the 48 hours after.  Migraines began on day 6 of each shot. Pain specific to left eye and migraine cluster on left side. Head sensitive to touch. Vision problems began on day 10 both times.  intermittent- white outs where vision was lost in left eye for 30 seconds to two minutes. Day 11 eye symptoms and headache the same- complete vision loss in left eye with white out that lasted for 4 hours each time. Migraine intensified to pain level of 10 unable to sleep or do daily activity. Blurred or smokey vision began on day 12 and lasted until day 19  currently still experiencing same symptoms on day 14 of second shot
"Scratchy" throat, dizzy, shortness of breath, and flushed approx. 10 minutes post vaccination.  Evaluated onsite at vaccine clinic by physician.  Received diphenhydramine 25MG PO.  VS normal and stable.  O2 Sat at 100%.  Monitored and observed for 60 minutes and D/C'd in stable condition.  Contacted by phone in AM of 12/24/2020 and states all sxs resolved yesterday evening.  Will receive 2nd dose of vaccine in hospital Allergy Clinic.
Extreme fatigue and soreness. Cold sweats and sickness. Effects lasted about 3 days. Long term reaction was diminished lung capacity and chronic fatigue. Stamina while physical activity was greatly decreased for 6 months.
Metal taste in mouth; This is spontaneous case report received from a contactable consumer, the patient. A 49-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: Bp7534), via an unspecified route of administration in the left arm on 19Mar2021 at 18:00 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma. Concomitant medications were not reported. The patient previously took amoxicillin and Advair and experienced drug allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination patient was not diagnosed with COVID-19. Since the vaccination the patient had not tested for COVID-19. On 19Mar2021 at 18:15, the patient experienced metal taste in mouth. The patient did not receive any treatment for the reported event. The clinical outcome of metal taste in mouth was resolved on an unknown date in Mar2021.   No follow-up attempts are needed. No further information is expected.
She reports waiting the allotted time of 15 minutes after receiving the Covid injection. She reports after the 15 mins. that she returned to her work area where co-workers commented that she had a red blotchy hive looking rash around her neck and upper trunk area. She denied any itching or SOB and reports that the blotches were noted for approx. 3 hours after shot. She was instructed prior to 2nd Covid shot to contact PCP with understanding voiced.
Hard lump at insertion site, very warm to touch at site, red, itchy, very sore, unable to move arm without significant pain. Headache for 24 hours.
Temp 101.7 Po since evening after TDAP given until seen in office on day 2. Fatigue + Myalgia X 2 days.
soreness; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 68-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In April 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were provided as follows:  Around 24th to 28 April 2019, the patient received 1st dose of Shingrix on left deltoid. Afterwards he had only some soreness in his left deltoid where he received the injection. For tolerance after 2nd dose, refer case US2019123027.