chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a medical assistant and refers to a 63 year old female patient. The patient's concurrent conditions included high cholesterol, prediabetes, hypothyroidism, asthma, sulfa allergy, penicillin allergy and allergy to VIACIN. The patient's concomitant therapies included PROZAC, SYNTHROID, simvastatin, DETROL and vitamins (unspecified). Information regarding the patient's medical history was not reported. On 02-OCT-2018, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 lot # R009162, expiration date 06-JAN-2020, intramuscular (dose and anatomical location were not provided), for prophylaxis. On the same date, hours after receiving the PNEUMOVAX 23, the patient experienced injection site swelling, hot to touch, fever, chills, pain and redness. It was reported that the patient sought medical attention, however the patient did not receive treatment for the events. No laboratory diagnostic studies were performed. It was reported that the improperly stored PNEUMOVAX 23 vaccine was exposed to a temperature of 32°F up to 35°F, during 10 hours. There was not previous temperature excursion. It was reported that digital data logger was involved. The outcome of injection site erythema, injection site swelling, injection site warmth, pyrexia, chills and injection site pain was reported as not recovered/not resolved. The causality between the events and PNEUMOVAX 23 was not provided.
It was so bad; Pain for two weeks; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced pain (Verbatim: Pain for two weeks) and feeling bad (Verbatim: It was so bad). Shingrix was discontinued. The outcome of the pain was recovered/resolved (duration 2 weeks) and the outcome of the feeling bad was not reported.   The reporter considered the pain and feeling bad to be related to Shingrix.     The company considered the pain and feeling bad to be related to Shingrix.   Additional Information: GSK Receipt Date: 10-MAR-2023 This case was reported by a patient via interactive digital media. The patient reported that the Shingrix vaccine was so bad and that he/she suffered from pain for two weeks after vaccination. The patient reported that he/she would not take second dose chances. The follow-up could not be possible as no contact details were available.
Sick; Cold bones; Chills; my BP went to the roof; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administered in arm right, administration date 07Apr2021 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "Sick"; FEELING COLD (non-serious), outcome "unknown", described as "Cold bones"; CHILLS (non-serious), outcome "unknown", described as "Chills"; BLOOD PRESSURE INCREASED (non-serious), outcome "unknown", described as "my BP went to the roof". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The product was Characterization role  in suspect drug. The Proprietary medicinal product name was Covid 19 vaccine. The reporter was Consumer or other non health professional . The case was HCP postal address. The Adverse Events were unspecified date Sick , Cold bones, Chills and Event were my BP went to the roof. The Covid 19 vaccine a Pfizer product unknown manufacturer  , NDC number of Covid 19 vaccine and UPC number of Covid 19 vaccine. The Reason for no lot number: of Covid 19 vaccine: Other: batch# ER87; My first LOT was 6207 and the second LOT was 8729, second shot and Expiry Date also Unknown. The Consumer stated, "I got shot on 07Apr2021 batch# ER87,  reporter got sick real sick on Thursday and I haven't done anything and reporter got real cold to the bones, like chills and reporter got shot on my right arm then patient went to Pharmacy on Monday and my BP went to the roof." When probed for the concern and asked was it the first shot or second shot:  consumer stated, "is this all blood pressure stuff because of shot. The reporter ain't getting nothing out of it, does this shot give you side effects. The Pfizer medical information department number was given.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Injection site reaction followed by multiple symptoms Narrative:  PMHx significant for Hashimoto's thyroiditis Wednesday afternoon 10/13 got booster dose The next morning 10/14 - there was a red mark at the injection site with swelling the size of a golf ball. It was hot and painful too. Her whole arm was swollen. Went to clinic and showed nurse her injection site reaction and she was sent to Employee Health. Saw Dr, Ibuprofen Benadryl Warm compresses Was referred and told she could go home to rest and treat. The warm compresses and Benadryl helped. 10/15 - mild HA 10/16 - stuffy nose, then around 1400 had body aches and chills so she took a nap. Felt better after her nap. 10/17 - under her chin was swollen and had hot flashes. Temp was 98.2/98.3. Felt like she had the flu. Mild cough intermittently. Felt better with resting. Took ibuprofen throughout the day. 1900 took Benadryl 12.5 mg. Then felt much better. Didn't have any trouble breathing or swallowing. 10/18 - This morning woke up and chin is less swollen. Didn't wake up feeling hot. Has a raspy voice. Tension in the sinuses. Ears are clogged. Called in sick today. Her arm swelling and redness has gone down. It's now dark brown and today it's not sore. Will f/u tomorrow for further assessment 10/19/2021 - employee reports she's doing better today. No longer has a hoarse voice. Yesterday she had a weird sensation on the tip of her tongue... as thought her tongue was cut. It felt raw. It lasted for about 15 min and then went away. She denies change in sense of smell or taste. Today she woke up feeling good. The swelling has disappeared from her clavicle and all other symptoms have resolved.
persistent high pitched cry, worst evening of vax, lasted 2-3 days; appeared to have pain when moved;
Breakthrough case after 4 vaccines  Moderna 3/3/21 Lot# 030A21A;  Moderna 4/3/21 Lot# 031B21A;  Moderna 12/10/21 Lot# 013F21A; Pfizer 8/1/22 Lot# FP7139
Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Medium, Additional Details: Patient received vaccine. Had not eaten anything that day prior to vaccination. Said he felt tired and closed his eyes for a minute but lost control of his bladder. Seemed shaky and sweaty. Blood pressure taken was low 90/50 initially at 222pm. Gave patient water and a protein bar. Blood pressure at 238pm 109/72. Blood pressure at 253pm 119/86. Seemed much improved after 30 minutes.
Headache for 7 days, Eye pain, Dizziness for more than 7 days, Head pressure, ringing in ears.
Slight Temperature; Site pain; This spontaneous case was reported by a patient and describes the occurrence of PYREXIA (Slight Temperature) and VACCINATION SITE PAIN (Site pain) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.    Co-suspect product included non-company product INFLUENZA VACCINE for an unknown indication.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form and dose of INFLUENZA VACCINE (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Slight Temperature) and VACCINATION SITE PAIN (Site pain). At the time of the report, PYREXIA (Slight Temperature) outcome was unknown and VACCINATION SITE PAIN (Site pain) had resolved.            No concomitant medication was reported. It was reported that patient had no side effects other than the site pain for just 2 days, and a slight temperature just like the Moderna jabs. No treatment medication was reported.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site rash in a 67-year-old female patient who received SHINGRIX (batch number 455KD, expiry date 4th May 2021) for prophylaxis. Previously administered products included SHINGRIX (1st dose received on an unknown date and did not have a reaction to it). On 5th February 2019, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. In February 2019, less than a week after receiving SHINGRIX, the patient experienced injection site rash and injection site nodule. On an unknown date, the outcome of the injection site rash and injection site nodule were not recovered/not resolved. It was unknown if the reporter considered the injection site rash and injection site nodule to be related to SHINGRIX.
30 MINUTES POST PFIZER COVID VACCINATION PT BEGAN TO FEEL ITCHY ON SCALP AND BACK OF HANDS. GAVE PT 25 MG OF BENEDRYL PO.  AFTER 20 MORE MINUTES ITCHINESS WAS RESOLVING.  PT WAS RELEASED TO BE DRIVEN HOME BY HER SISTER. PT WAS ADVISED TO MONITOR HER SYMPTOMS, AND TO SEEK MEDICAL ADVICE OR ATTENTION IF SYMPTOMS WERE TO PERSIST OR WORSEN.  SHE WAS ADVISED TO CALL 911 IF SHE HAD A MEDICAL EMERGENCY.
Suspected Vaccination failure; Got meringite and is now completly deaf; Autistic; now completly deaf; This case was reported by a consumer via interactive digital media and described the occurrence of  suspected vaccination failure in a male patient who received Men B NVS (Meningococcal B vaccine) for prophylaxis.   On an unknown date, the patient received Meningococcal B vaccine. On an unknown date, unknown after receiving Meningococcal B vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), meningitis (serious criteria GSK medically significant), autistic disorder (serious criteria GSK medically significant) and deafness (serious criteria GSK medically significant). On an unknown date, the outcome of the vaccination failure, meningitis, autistic disorder and deafness were unknown.   It was unknown if the reporter considered the vaccination failure, meningitis, autistic disorder and deafness to be related to Meningococcal B vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The reporter knew somebody who was vaccinated got meningitis and was now completely deaf. The reporter stated that he or she was talking about vaccinated and plus been deaf and he was autistic too at  the time of reporting. The reported said, open your eyes people, they did not want us healthy. This case was considered as suspected vaccination failure as details regarding vaccination schedule, type of meningitis, time to onset for target disease and laboratory confirmation were unknown at the time of reporting.
Erythema 3.5 x 3.5 with 2 x 2 cm induration at site of injection (L) thigh and warm to touch cellulitis.
aches; Chills; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills) and PAIN (aches) 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 an unknown date, the patient experienced CHILLS (Chills) and PAIN (aches). At the time of the report, CHILLS (Chills) and PAIN (aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not reported. Treatment medication was not reported.    Reporter did not allow further contact
Headache began early afternoon and gradually the pain increased through the remainder of Friday March 5,2021 and lasted through Saturday, March 6,2021 until about 6 PM where the pain subsided enough that I could function. As the pain intensified, I had throbbing pain in the temples and behind my eyes, the pain worsened even more if I bent forward, like to pick up something from the floor. My neck muscles were extremely tight. I couldn't concentrate on anything, like reading or working.  I was feeling less than energetic,. Also, my left arm was red, not swollen at the injection site and hurt to touch, not as bad as the 2 days after receiving the vaccine, but I thought it was unusual that my arm was red & sore. This is what made me conclude it was a delayed reaction to the vaccine. I rarely have headaches and if I do  taking 2 Ibuprofen will take care of it. Taking 2 Ibuprofen this time did absolutely nothing to ease the pain.  I did increase to 800 mg of Ibuprofen late Friday and early Saturday which did help, used a cervical heating pad, hot shower to try to ease muscle tension. I was able to sleep and by Saturday evening with home remedies, the pain did subside and by Sunday March 7,2021 I felt back to normal with a slight, slight bit of headache but not much to worry about.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BREAST TENDERNESS (non-serious), outcome "unknown", described as "Breast tenderness". Additional information: Caller stated that she has three other women that have had breast tenderness from this. Is for the Pfizer Covid vaccine. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101878669 Same reporter/ drug/ event for different patients.; US-PFIZER INC-202101878670 Same reporter/ drug/ event for different patients.; US-PFIZER INC-202101877385 Same reporter/ drug/ event for different patients.
Approximately 2 hrs after PNEUMOVAX in right arm unable to move, bend or stretch arm without significant pain, swollen a lot, also became hot. Lasted 3 days significantly till subsided slowly.
Patient woke-up around 5:00 am and parent noticed swelling behind patient's right ear (approx size of a golf ball).  Patient had a very restless night sleep.
Patient experienced hives/rash breaking out on face, chest, and stomach.  Also experienced a scratchy throat and scratchy eyes.  All this began approximately 30 minutes after receiving the vaccine shot.
about 2 weeks ago started to have facial swelling where filler was/but only on one side; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (about 2 weeks ago started to have facial swelling where filler was/but only on one side) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Dermal filler injection (Patient had fillers placed in cheeks about two week  ago) in 2021.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SWELLING FACE (about 2 weeks ago started to have facial swelling where filler was/but only on one side). At the time of the report, SWELLING FACE (about 2 weeks ago started to have facial swelling where filler was/but only on one side) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported  Treatment included steroids   Reporter did not allow further contact
I started getting a horrible migraine/sinus pain headache early evening the day of the vaccine.  The left side of my face had tremendous pressure.  The pounding in my head was so intense it upset my stomach to the point of nausea.  The pain also went down into my neck.  At around 10am the next day it finally subsided.  I did take Ibuprofen around 8am that morning.  I felt completely drain that entire day and evening.  Also I had arm tenderness at the area around the vaccine.  I did arm raises through the day to help keep arm pain down and it helped.  The arm tenderness is still occurring 2 days after the shot (which is the day I am filling out this form).
Friday 1/22-11am recived shot  3pmLeft arm soreness 4hrs after then started to feel the flu like symptoms chills severe body ache joints pains temp 104 one time then down to 99.8. Until Sat 3pm starts ti feel ok but buy sunday started the chills and achy joints and body ache again.then temp 101 in early morning of  monday.the whole day gets better until ealry am of tuesday got the chills and joint pains.been on rtc ibuprofen 800mg and tylenol 500mg thr whole time.im still monitoring myself until today while im reporting this.
felt ill; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and MALAISE (felt ill) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     The patient's past medical history included Fracture (fracture in back).    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On an unknown date, the patient experienced MALAISE (felt ill). The patient was treated with Manual therapy (Ice pack) for Pain in extremity. At the time of the report, PAIN IN EXTREMITY (Sore arm) and MALAISE (felt ill) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing was delayed on an unknown date.       Concomitant products include muscle relaxers, and pain medication.  Treatment information was not provided.   This case was linked to MOD-2021-075141 (Patient Link).
03/20/2021 had a mild headache, every other day, not bad enough to take meds, but I never have headaches otherwise. On 03/24/2021 had an episode while sitting and watching tv where room went dark, felt "spaced out..things werent in focus correctly..vision was blurry." Felt "high". Lasted about 15 ?20 min then resolved. 06/01/2021 Right leg Calf is red and swollen. 06/11/2021 Saw Dr. Sent me to Emergency. They completed Ultra sound. Determined Cellulitis infection. Gave me antibiotic. On 07/11/2021 Received more antibiotic CEFADROXIL. 07/25/2021 Went to Emergency due to pain. Had ultrasound. Determined blood Clot in right leg. Given Xarelto medication. 08/13/2021 swelling is going down, calf is softer
Joint pain; Has a little bit of pain in her finger on the left hand; This is a spontaneous report received from a contactable consumer (patient). A 66-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration in the right arm, on 04Jan2021 15:45, at single dose, for COVID-19 immunization, in her workplace. Medical history included ongoing arthritis (has been cold there) and Crohn's disease so the patient has a tendency to have inflammation. Concomitant medication included vedolizumab (ENTYVIO). The patient experienced joint pain and had a little bit of pain in her finger on the left hand on an unspecified date in Jan2021. Treatment included Salonpas and Tylenol. The outcome of joint pain was recovering (reported as ongoing but a little better); and "has a little bit of pain in her finger on the left hand" was unknown.  Information on the batch/lot number has been requested.
Her arm is getting blotchy; She is fatigue like very quickly; She would be walking around doing her chores and she is like to pee and start crying; Her arm is like swelling; It's kind of skin peeling off kind of where she got the shot; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 22 year-old female patient received bnt162b2 (BNT162B2), administered in arm left (Batch/Lot number: unknown) as dose 2, single and administered in arm left, administration date 20Aug2021 (Lot number: FE3592) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Endometriosis" (unspecified if ongoing); "Birth control" (unspecified if ongoing). Concomitant medication(s) included: LORYNA taken for contraception. Past drug history included: Augmentin, reaction(s): "Allergic to Augmentin". The following information was reported: RASH MACULAR (non-serious) with onset 01Sep2021, outcome "unknown", described as "Her arm is getting blotchy"; FATIGUE (non-serious) with onset 01Sep2021, outcome "unknown", described as "She is fatigue like very quickly"; CRYING (non-serious) with onset 01Sep2021, outcome "unknown", described as "She would be walking around doing her chores and she is like to pee and start crying"; SWELLING (non-serious) with onset 01Sep2021, outcome "unknown", described as "Her arm is like swelling"; SKIN EXFOLIATION (non-serious) with onset 01Sep2021, outcome "unknown", described as "It's kind of skin peeling off kind of where she got the shot". Therapeutic measures were taken as a result of rash macular, fatigue, crying, swelling, skin exfoliation.  Additional information: Reporter stated, "He was calling because his fiance she just took the COVID vaccine through Pfizer and he think it was 20Aug2021 was first shot and second shot she took was two days ago. He was noticing her arm was getting blotchy, she was fatigue like very quickly, she would be walking around doing her chores and she was like to pee and start crying, so he don't know weather and her arm was like swelling, and it's kind of skin peeling off kind of where she got the shot, so he just wanted to what if he can question was like anything have you heard about this, was there anything he can do to mitigate the symptoms and he don't know what going on. "Age when adverse event started: Reporter stated, "So her age, she was 22 (not clarified hence not captured in tab) going to be 23 she started having the first symptom, he don't know, he was just trying to track it, she had the first symptom 01Sep2021 (Confirmed as start date of adverse event as 01Sep2021) and she got her vaccine on the 20Aug and the next dose, her next dose was on the 10th of this month and she feeling symptoms today that was the 11th, so she was feeling one day after shot". Treatment received was "Ibuprofen 800 mg.   Follow-up attempts are completed. No further information is expected.