chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Headache; Severe Pain In Left Hand; Overall Body Aches; Low Grade Fever 101.3; NAUSEA; Fatigue; This is a spontaneous report received from a contactable consumer (patient). This 68-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection Lot Number and Expiration Date was not reported), via an unspecified route of administration in left arm on 26Feb2021 at 12:30 PM, as 2nd dose, single dose for covid-19 immunisation. Patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Solution for injection, Batch/lot number: EL9269, Expiration date: unknown), via an unspecified route of administration in right arm, on 07Feb2021 at 1:15, at a single dose for covid-19 immunization. The patient's medical history, known allergy and concomitant medications were not reported. The patient did not receive any other medication in four weeks. She received progesterone: furazolidone, metronidazole (DIM), adk, and eszopiclone (LUNESTA) in two weeks. The patient did not have covid prior vaccination. On 27Feb2021 at 1:30, the patient experienced headache, serve pain in left hand, overall body aches, low grade fever 101.3, nausea, and fatigue. No treatment was received for the AE. The outcome of events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
shingles; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   In November 2021, the patient received Shingrix. On an unknown date, 1 day after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   The reporter considered the shingles to be possibly related to Shingrix.     Additional Information: GSK Receipt Date: 27-Sep-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient received the booster vaccine. The next day patient developed the shingles. Additional Supportive Information: The follow up would not possible, as no contact details were available.
Several days of fatigue and headache, pain in left arm right after vaccine. Then few weeks later, I started having severe pain at the base of my spine near the rectum which ended up being diagnosed as hemorrhoid's. I have never had this problem, and I have been healthy for many years. It took about 2-3 weeks to fully subside during which time it was very hard to work due to the pain.
5/11/01 pt rec'd immunizations 3:30pm 4/27/01 in the evening 4/28/01, had trouble breathing and had to use inhaler continued to use inhaler 4-6 x day through out the next several days (normally she uses it 1 x day) On Wed am 5/2/01 her L arm was sore where she received the yellow fever vaccine. She put a cool cloth on it and took advil. On 5/4/01 pt began itching all over her body - rash was over body but raised on her arms and she went to the ER. They gave her Prednisone and sent her home on it. She called her allergist Mon. because she couldn't sleep on the Prednisone - cut Prednisone down to 1x day until Wed. 5/9/01. She continues to use inhaler 3x day now. States she had food poisoning yesterday no N/V today. R arm is red at injection site - no more rash. Pt states L arm throbbed from shoulder to wrist for about 2 wks after receiving YF injection. Skin over injection site peeled - no bigger than a dime - no other problems.
This case was reported by a consumer via call center representative and described the occurrence of handicap in a 72-year-old male patient who received SHINGRIX (batch number N9CA2, expiry date 2nd July 2021) for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of adverse event (1st dose received on an unknown date, refer case US2019GSK043646) and prednisone. Concurrent medical conditions included multiple sclerosis. On 21st February 2019, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. In February 2019, 7 days after receiving SHINGRIX, the patient experienced stomach cramps, general body pain and difficulty in standing. On 21st February 2019, the patient experienced influenza-like symptoms and walking difficulty. On an unknown date, the patient experienced handicap (serious criteria disability and GSK medically significant) and sickness. On an unknown date, the outcome of the handicap and sickness were unknown and the outcome of the influenza-like symptoms, stomach cramps, general body pain and difficulty in standing were recovered/resolved and the outcome of the walking difficulty was not recovered/not resolved. It was unknown if the reporter considered the handicap, influenza-like symptoms, walking difficulty, stomach cramps, general body pain, difficulty in standing and sickness to be related to SHINGRIX. Additional details were reported as follows: The patient received SHINGRIX vaccine on right arm. The same night of vaccination, the patient experienced flu like symptoms, and had trouble walking. This was lasted for 2 days and he started feeling better. About a week later, the patient experienced stomach cramps, stomach pain, flu like symptoms, body aches, trouble walking and trouble standing up. The patient had some prednisone lying around that he started taking that he uses for his multiple sclerosis. In 2019, less than a month after receiving SHINGRIX, the patient was sick and handicapped and no one was able to take care of him. The patient recovered from all the symptoms except he was still having trouble walking and standing up. The reporter consented to follow up. No further details were provided. This case has been linked with case US2019041402, reported by same reporter. (Patient's wife).
sudden swelling @ site of inject 5 cm induration; no systemic rxn DPh given;
pt devel petechial rash; Dx as ITP; tx w/IVIG;
Below is copied from web message sent by patient yesterday: Extreme pain when the injection was given. I developed severe pain within an hour of the injection. I have never had pain like this before. Any movement of my left arm was excruciating. I had to pull off the road twice driving home that night. I used ADVIL and a cold pack through the night but couldn't lay down or sleep. By the morning I was able to change my clothes for work but I still can't completely raise my left arm. Dr. and myself left voice mails for pt to check on her status but have not heard back yet.
This case was reported by a consumer via other manufacturer and described the occurrence of allergic reaction in a elderly female patient who received SHINGRIX for prophylaxis. The patient's past medical history included drug allergy (allergic to DEMEROL). Previously administered products included SHINGRIX with an associated reaction of paraesthesia (refer case US2018GSK213488). On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced allergic reaction (serious criteria hospitalization), hives and scar. On an unknown date, the outcome of the allergic reaction and hives were recovered/resolved and the outcome of the scar was not recovered/not resolved. It was unknown if the reporter considered the allergic reaction, hives and scar to be related to SHINGRIX. Additional details were provided as follows: This case was reported via Merck National Service Center. The age at vaccination was not reported, the patient was in her 80's. The patient received the SHINGRIX booster shot 6 months after receiving 1st dose. After receiving the 2nd dose the patient developed a terrible allergic reaction and developed hives and welts and was hospitalized (unspecified details). The patient received unspecified treatment at the hospital and was recovered at the reporting time, but she had ugly scars on her skin from the reaction to the vaccine. In addition the patient was allergic to DEMEROL and asked if the vaccine contained that product. No further adverse event information was provided.
A 2 inch across red welt was noticed the morning of 12/18/11.  The welt and redness began to fade on 12/20/11.  As of 12/22/11, the welt had decreased to a faint pink spot.
Information has been received from a physician concerning a 24 month old male who on 29May05 was vaccinated with a dose of varicella virus vaccine live. On 03Jun05 the pt developed a rash/breakthrough, described as 8 lesions around the trunk, arm, and neck. He was noted to have a fever prior to the lesions. Unspecified medical attention was sought. The outcome was reported as recovering. No further information was available. There was no product quality complaint. Additional information has been requested.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) 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 was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment; Positive, notes: Covid rebound. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient had no other medication in 2 weeks. The patient received anti-viral as COVID 19 Treatment. Covid rebound case after completing medication series.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
I received the injection at 2pm and around 8pm my tongue  and the inside of my mouth began to tingle. Both my tongue and the roof of my mouth became extremely tender and sore to touch my teeth. My throat and jaw became uncomfortable, but my airway was never compromised. The soreness has lasted 3 days and has eased with the help of Benadryl  each day.
I received the Johnson vaccine , At the time i felt tired and have been feeling since then and off and on again tired episodes my low back is constantly hurting and i feel like i need to be stretched out if i move my body to the side slightly i all of sudden feel a tingling sensation on my skin more on my stomach skin and it goes to my tongue it goes away but it stays throughout the day  I suddenly feel like a metal/ acidic taste on my mouth when the tingling is happening.  I also noticed that my legs are slow to respond like when i get up and walk i feel my legs heavy . Also have noticed im slurring a lot of words at times like my tongue cant move  and notice a tingling sensation along with it.
Mother called on 11/04/2013 to report that child woke up next am after shots with large red whelps all over body, very hot to touch, face and eyes swollen and red, no fever.  Health unit has requested parent provide a copy of medical notes from office visit to MD.
Hives on neck, head, upper thigh area. Mainly around lymph node sites. Began within a few days of the vaccine and still continue as of 01/21/2023. Very itchy.  I have been taking Allegra, Benadryl and using hydrocortisone cream. But they never go away.
Week after vaccination, my arm is swollen, hard as a rock, and skin is red at the place where I received the shot. Swelling is the size of a golf ball. Painful.
Patient was admitted with acute hepatitis, treated and released. Hospital admission within 6 weeks of receiving the COVID vaccine. ED visit for anxiety - no medical treatment, released.
Pt vaccinated with DTP developed erythematous area - 3 X 3.5 CM, over injection site. Area swollen & warm; not tender.
Vaccine was given in right arm on Thursday 07/08/2010 in the AM at facility. Allergic reaction occured on 07/13/2010 around the area where vaccine was given.
Left upper arm swelled up and lymph glands in left axilla became swollen and painful.  Chills alternating with sweats and headache and nausea.
No adverse effects; One patient received properly stored M-M-R II which was reconstitued with properly stored preservative free normal saline instead of the sterile diluent; One patient received properly stored M-M-R II which was reconstitued with properly stored preservative free normal saline instead of the sterile diluent; This spontaneous report was received from a medical student and refers to a 19 year old patient of unknown gender. The patient's medical history, concomitant medications, drug reactions or allergies were not reported.  On 13-APR-2019, the patient was vaccinated with a properly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) lot # R031681, expiration date: 01-NOV-2020 (dose, frequency, route of administration and anatomical location were not provided) as prophylaxis. On that day, the vaccine was reconstituted with a properly stored preservative free normal saline (lot# and expiration date not provided), instead of the sterile diluent (wrong technique in product usage process, product preparation error).  No adverse effects were reported.
Warm to touch at the injection site; A very big , red area at the injection site; Injection site which is also swollen; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Warm to touch at the injection site), VACCINATION SITE ERYTHEMA (A very big , red area at the injection site) and VACCINATION SITE SWELLING (Injection site which is also swollen) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jan-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 VACCINATION SITE WARMTH (Warm to touch at the injection site), VACCINATION SITE ERYTHEMA (A very big , red area at the injection site) and VACCINATION SITE SWELLING (Injection site which is also swollen). At the time of the report, VACCINATION SITE WARMTH (Warm to touch at the injection site), VACCINATION SITE ERYTHEMA (A very big , red area at the injection site) and VACCINATION SITE SWELLING (Injection site which is also swollen) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       There was no concomitant medication reported. There was no relevant treatment medication reported.   Most recent FOLLOW-UP information incorporated above includes: On 29-Jun-2021: Follow-up was received on 29-JUN-2021, contain significant information. Changed the outcome of all the events,from unknown  to recovered/resolved.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Administered with the vaccine which has been stored in the refrigerator for more than 30 days; Administered with the vaccine which has been stored in the refrigerator for more than 30 days; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered with the vaccine which has been stored in the refrigerator for more than 30 days) and PRODUCT STORAGE ERROR (Administered with the vaccine which has been stored in the refrigerator for more than 30 days) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Jul-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered with the vaccine which has been stored in the refrigerator for more than 30 days) and PRODUCT STORAGE ERROR (Administered with the vaccine which has been stored in the refrigerator for more than 30 days). On 19-Jul-2021, EXPIRED PRODUCT ADMINISTERED (Administered with the vaccine which has been stored in the refrigerator for more than 30 days) and PRODUCT STORAGE ERROR (Administered with the vaccine which has been stored in the refrigerator for more than 30 days) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication reported. No treatment information was provided.   This case was linked to MOD-2021-265450 (Patient Link).
Hives, swelling, joint pain, fever, nausea, vomiting, exhaustion still lasting at 3 weeks post vaccine
Fever started afternoon of 4/10 and lasted until morning of 4/11. Took ibuprofen every 4-6 hours  Large red and swollen welt at injection site, watm and painful to touch. Started 4/10, still have it as of 4/12. Taking ibuprofen for pain.
I experienced normal pain in my arm following a vaccination. Then it started to be very painful. So painful that I had trouble using my arm to do things because I had severe pain in my shoulder. I went to the doctor and they completed an X-ray. I also went to physical therapy. I then went to an Orthopedic doctor who advised me that I could continue physical therapy a few days after the injection, and I should return for a follow up visit. The orthopedic doctor determined the issue I was having was related to the vaccine and as a result I was given a Cortisone injection. I had pain in both shoulders as I received my 1st dose in my left arm and my 2nd dose in my right arm. When I received my 1st dose in my left arm, my arm was panful and stiff. I took medication for the inflammation. An X-ray was completed for this arm as well. I also received a Cortisone injection for the left arm. My left arm was diagnosed as a frozen arm, and I had inflammation in the right arm.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Nov2021 as dose 3 (booster), single at the age of 65 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Drug ending in-cillin" (unspecified if ongoing), notes: Drug ending in-cillin. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible. No further information is expected.
Approximately 12 hours after injection,I experienced a clogged milk duct and mild mastitis in the breast on the same side as my injection. The affected duct was near the armpit. My lactation consultant suggested that other lactating mothers had had this experience immediately following their injection and that reporting it may influence providers to administer the injection in the thigh for this demographic.  I also had a stronger vaccine reaction this time around, with chills and achiness not experienced with the first two injections.
Patient became very lightheaded, pale, nauseous and sweaty.  We had her lie down and applied a cold compress and elevated her feet.  Her blood pressure dropped to 68/41 with pulse of 70.   A physician assessed her symptoms and recommended monitoring her vital signs until patient felt better.  Her blood pressure continued to improve and approximately an hour after receiving the vaccines her blood pressure measured 92/59 and her pulse was 90.  She felt much better and left the clinic.
Taken to hospital and reported that patient had been breaking out for the past 2 hours beginning location: back, arms, legs. Itching was noted. No treatment at hospital other than Benadryl as needed. At physician's office on 7/29/14, presented with scattered erythematous, pruritic papules scattered on back, buttocks, arms and legs. Diagnosed with varicella and told to monitor and return for any new or worsening symptoms or failure to improve. No medications given at this time.
Swelling and redness over left thigh (injection site). Parents applied heated aloe vera which decreased the swelling. Brought to office on 3/4/2010 for a check up of the swelling and just noted erythema over the injection site. No swelling, no tenderness. No wheezing, no oral lesions.
Information has been received from a certified medical assistant, concerning a 52 year old male with no medical history or allergies, who on 07-DEC-2008, was vaccinated with PNEUMOVAX (Lot # 659150/1384U), 0.5ml, intramuscularly.  Concomitant therapy included PROTONIX.  The certified medical assistant reported that , on 09-DEC-2008, the patient developed a fever of 100.2F, swelling, redness and pain at the injection site (right arm).  The patient was seen on 10-DEC-2008 and was diagnosed with cellulitis and allergic reaction to the vaccine.  The patient was treated with VICODIN and PREDNISONE.  No other details.  It is unknown if the patient recovered.  Additional information has been requested.
RIGHT FOOT RASH; REPORTED 1 WEEK AFTER INITIAL VISIT; ALERTED PHARMACY WHEN SHE CAME IN FOR THE 2ND DOSE ON 2-16-21.
diarrhea; stomach cramps; vomiting; excruciating headache/mild headache; had chills; had  cold; body was warm and had chills; pain in sinus; was nauseated/mild nausea; had metal taste; This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (had metal taste), NASOPHARYNGITIS (had  cold), FEELING HOT (body was warm and had chills), SINUS PAIN (pain in sinus) and DIARRHOEA (diarrhea) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 15-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jul-2021, the patient experienced DYSGEUSIA (had metal taste) and NAUSEA (was nauseated/mild nausea). On 16-Jul-2021, the patient experienced NASOPHARYNGITIS (had  cold), FEELING HOT (body was warm and had chills), SINUS PAIN (pain in sinus), CHILLS (had chills) and HEADACHE (excruciating headache/mild headache). On 18-Jul-2021, the patient experienced DIARRHOEA (diarrhea), ABDOMINAL PAIN UPPER (stomach cramps) and VOMITING (vomiting). The patient was treated with IBUPROFEN for Adverse event, at a dose of 1 dosage form. At the time of the report, DYSGEUSIA (had metal taste), NASOPHARYNGITIS (had  cold), FEELING HOT (body was warm and had chills), SINUS PAIN (pain in sinus), DIARRHOEA (diarrhea), ABDOMINAL PAIN UPPER (stomach cramps), CHILLS (had chills), VOMITING (vomiting), HEADACHE (excruciating headache/mild headache) and NAUSEA (was nauseated/mild nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.
Mild swelling of upper left arm, mild erythema approx. 5x5 cm from.
pt states she began having pain in her arm the next day after injection. States she saw her pcp who advised her to use ice/heat. States that she also saw physical therapist for her discomfort who gave her stretching exercises. She states that pain in left arm is still bothering her and that she can barely lay on it at night.