chrisvoncsefalvay/vaers-outcomes huggingface dataset:
ROTATEQ, PEDV AX HIB, RECOMBIV AX HB, GARDASIL 9 and VAQTA that went out of range were potentially administered; No additional adverse effect reported; Information has been received from a nurse istant and refers to a patient of unknown age and gender. There was no information about patient's concurrent conditions, medical history, concomitant medications or drug reactions/allergies.  On unknown dates, the patient was potentially vaccinated with doses of the following vaccines that were out of range: hepatitis b vaccine (recombinant)(RECOMBIVAX HB), lot # R028529 and expiration date of 09-JUN-2021, lot # T004378 and expiration date of 01-NOV-2022 and lot # R021372 and expiration date of 25-MAY-2021, hepatitis a vaccine, inactivated(VAQTA) lot # T020442 and expiration date of 26-JAN-2022 and lot # T014835 and expiration date of 17-JUL-2021, haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) lot # T001208 and expiration date of 09-JUN-2022 and lot # T020615 and expiration date of 13-MAR-2023, hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot number 1621926 and expiration date of 28-NOV-2021 and lot # 1602284 and expiration date of 26-SEP-2021 (route of administration and anatomical location were not reported) and with rotavirus vaccine, live, oral, pentavalent(ROTATEQ) lot # 1676322 and expiration date of 21-APR-2021, lot # 1688822 and expiration date of 20-NOV-2021 and lot # 1691301 and expiration date of 12-DEC-2021 per oral route, all for prophylaxis, which were stored in the following ranges: 9 Celsius degrees to 25 Celsius degrees (8.53 Celsius degrees) for 15 minutes and 9 Celsius degrees to 25 Celsius degrees (11.6 Celsius degrees) for 45 minutes.  No previous temperature excursion was reported. No additional adverse effects were reported.  Digital data logger was involved.  This is one of several reports from the same reporter. ; Sender's Comments:  US-009507513-2103USA003717: US-009507513-2103USA005236: US-009507513-2103USA005238: US-009507513-2103USA005239: US-009507513-2103USA005240: US-009507513-2103USA005241: US-009507513-2103USA005234: US-009507513-2103USA005233: US-009507513-2103USA005235:
Chronic dull pain in biceps, triceps and shoulder with rare episodes of sharp  pain shooting from the shoulder. Occurs at rest and with mild use.
HAND PAIN (RHEUMATOID ARTHRITIS); LETHARGIC; BODY ACHES; EYE PAIN; CHILLS; FEVER; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry: unknown) dose was not reported, frequency once total, administered on 26-MAR-2021 at left arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  It was reported that the patient did not feel any symptoms until 01-APR-2021.  On 01-APR-2021, the patient experienced hand pain described as rheumatoid arthritis, lethargy, body aches, eye pain/ocular pressure, chills and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from lethargic, body aches, fever, chills, eye pain, and rheumatoid arthritis. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210409942-Covid-19 vaccine ad26.cov2.s-Hand pain (Rheumatoid arthritis). This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
got the vaccine and got shingles/uspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional details were reported as follows: The case was reported by the patient's friend. The age at vaccination was not reported. The patient got the vaccine, and still got shingles, apparently, it must fall under the Center for Disease Control and Prevention (CDC's) guidelines as the covid vaccine.  The reporter also said, in other words, it was not. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation were unknown at the time of reporting. No contact details were available.
Erythema and buccal swelling, left cheek, onset 18 hours after vaccine. No lip or tongue swelling. No respiratory difficulties.
Oct 3, 2011, vaccine given in left arm. Extreme bruising on inside of left arm from armpit down to & including hand. Vomited at midnight, very sore, couldn't raise arm very high. Lasted (bruising) two plus weeks. NP requested that I come in so she can see what happened. (10/7/11)
Bell's palsy is reported in pt 1 day p/receiving fluogen; No further med info is available;
About 9 days after injection I developed a small pink area 2x2. Which was about an inch beneath the injection site.  Never itched or hurt.  Slowly faded about a week later.  I called the county hot line and was told to report the finding when I get the next shot which is tomorrow.
Moderna COVID-19 Vaccine EUA 05/11 two hours after the vaccine my entire upper arm became red and hard to the touch and very hot 05/12  at 3am I woke up with a migraine, severe joint pain (knees, elbows, back, neck) and a fever of 101F these symptoms persisted all day and I went to sleep in significant pain.  05/13 at 6am I woke up drenched in sweat, my joints ache but less that on the 12th, fever is gone, but any movement causes my head to spin violently. The one time I?ve managed to get out of bed the dizziness was so bad I vomited.  My injection site arm is still red and hard and hot to the touch.
On 8/14/2022 I had a scratchy throat; I was not thinking really clear. I did a home test and it kind of came back positive. The next morning, 8/15/2022, I took another test, and it was positive. I went to a testing site, and it came back positive as well. I had fever congestion, fatigue.  After I got the results from the test, the doctor called me and suggested I do the antibody infusion on 8/16/2022 due to my kidney issues. I did not feel well for at least 8 to 10 days. I finally tested negative 17 days afterwards. Ever since then I still have a low-grade headache and I am a little bit foggy, not terrible, but just a little bit. The headache comes and goes a little bit, but it is kind of there most of the time.
On 06/18/2022 I began to notice a scratchy throat while on vacation. My symptoms continued to progress with stuffiness in the ears and sinuses and a worse sore throat, but I thought it was just a cold. While flying home we experienced a lot of delays and it took around 23 hours. The flying made my ears worse and by the time I got home, I was feeling pretty bad but I was still thinking it was a cold and the travel making me feel unwell. I tested for COVID-19 with an at home test and it was positive. I emailed my doctor who prescribed PAXLOVID which I took for the recommended five days. I was still experiencing some symptoms like fogginess and headaches and I was still feeling congested in my ears and sinuses. I was treating my congestion with saline spray and taking ADVIL for headaches. My symptoms lasted until 06/29 or 06/30 but when they went away, they were all gone completely and I felt like my normal self again.
Red area around injection site the day of injection, lasting 48 hours.  After 13 days I started feeling extremely nauseated and dizzy.  For over 48 hours, I felt very weak and had episodes of very low blood pressure .
This spontaneous report was received from a nurse concerning an unspecified number of patients of unknown age and gender. On an unknown date the patients were vaccinated with improperly stored ROTATEQ oral (dose, lot number and expiration date were not provided). Concomitant medications were not reported. No adverse effects were reported and there was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Vaccine is given 30 days from storage and is expired; administered with expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered with expired vaccine) and PRODUCT STORAGE ERROR (Vaccine is given 30 days from storage and is expired) in a female patient of an unknown age who received mRNA-1273 (Spikevax) (batch no. 013H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Mar-2022 at 10:54 AM, the patient received second dose of mRNA-1273 (Spikevax) (Intramuscular) .5 milliliter. On 30-Mar-2022 at 10:54 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered with expired vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine is given 30 days from storage and is expired). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered with expired vaccine) and PRODUCT STORAGE ERROR (Vaccine is given 30 days from storage and is expired) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. The vial was initially stored in the refrigerator on 01-Mar-2022 Vial did not undergone to any temperature excursion. No treatment medications were reported.
This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 77-year-old male patient who received SHINGRIX (batch number 9CC72, expiry date 18th May 2021) for prophylaxis. Previously administered products included SHINGRIX (1st dose received in July 2018 at an outside facility, batch number and expiry date was not provided). In February 2019, the patient received the 2nd dose of SHINGRIX (intramuscular). On an unknown date, several days after receiving SHINGRIX, the patient experienced shingles, malaise, nausea, night sweat, tingling and pain. The patient was treated with valaciclovir hydrochloride (Valtrex). On an unknown date, the outcome of the shingles, malaise, nausea, night sweat, tingling and pain were not recovered/not resolved. It was unknown if the reporter considered the shingles, malaise, nausea, night sweat, tingling and pain to be related to SHINGRIX. Additional details were reported as follows: In early February 2019, the patient received SHINGRIX. The exact date was not provided. The patient was diagnosed with shingles a couple of days after receiving SHINGRIX vaccine. In 2019, less than year after receiving SHINGRIX, the patient experienced classic symptoms of shingles, including malaise, nausea, night sweats, tingling at the sore site. The patient was being treated with Valtrex for the shingles.
This spontaneous report was received from a healthcare referring to a 68 year old patient of unknown gender. The patient's had no medical history, concurrent conditions or concomitant medications. On 11-JUN-2018, the patient was vaccinated with PNEUMOVAX 23 0.5 ml, once, lot in the left deltoid, lot number N034525 and expiration date of 13-SEP-2019 for prophylaxis (route of administration was not reported). On 12-JUN-2018, the patient got back to the office with complains of redness, swelling and itching at injection site. The patient was treated with "some OTC medicine" and BENADRYL for itching. There were no laboratory diagnostics or studies performed. At the time of the report, the outcome of redness, swelling and itching at injection site was reported as resolving. Additionally, the reporter did not provide causality assessment between the events and vaccination with PNEUMOVAX 23.
MN 22MAY97 fever, 39.3C (ax) high pitched cry lasting 20min occured twice during the noc APAP given x2;fever gone by Mid morning;seen by MD 23MAY97 no sign of ear infect or other infect;
Numbness and tingling on the left side on the day of vaccination.  On the 3rd day, arm began to swell and became reddened.
Constant, daily headaches; dizziness; vertigo; disorientation; brain fog  Vestibular rehab - ongoing, medication (so far ineffective, CT, MRI, bloodwork, ultrasound
Headache, Fever, Sore Muscles, soreness at injection site Narrative:
Severe inflammatory reaction causing polymyalgias, enthesopathy, polyarticular joint pain. Hypertension
The vaccine recipient received the vaccine on 12/16/2020. On 12/17 they reported pain at the injection site. On 12/18 and 12/19 they reported that they became with the following symptoms: swollen glands, body aches, fatigue, and sore throat. During a follow-up phone call they reported that the symptoms have resolved 12/20.
rectangular skin lesion (redness and erythema); rectangular skin lesion (redness, erythema) which is tender to touch on the inner aspect of her left thigh; tenderness on right shoulder jont; bursitis; This spontaneous case was reported by an other health care professional and describes the occurrence of TENDERNESS (tenderness on right shoulder jont), BURSITIS (bursitis), SKIN LESION (rectangular skin lesion (redness and erythema)) and TENDERNESS (rectangular skin lesion (redness, erythema) which is tender to touch on the inner aspect of her left thigh) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Apr-2021, the patient experienced TENDERNESS (tenderness on right shoulder jont) and BURSITIS (bursitis). On 03-May-2021, the patient experienced SKIN LESION (rectangular skin lesion (redness and erythema)) and TENDERNESS (rectangular skin lesion (redness, erythema) which is tender to touch on the inner aspect of her left thigh). The patient was treated with PARACETAMOL (TYLENOL) for Bursitis, at a dose of 1 dosage form. At the time of the report, TENDERNESS (tenderness on right shoulder jont), BURSITIS (bursitis), SKIN LESION (rectangular skin lesion (redness and erythema)) and TENDERNESS (rectangular skin lesion (redness, erythema) which is tender to touch on the inner aspect of her left thigh) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 31-May-2021: NNI.
soreness at injection site; lethargy; This is a spontaneous report from a contactable consumer (patient). A 26-year-old male patient received second dose of BNT162B2, (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EL3247) via an unspecified route of administration, administered in Arm Right on 09Feb2021 09:45 (at the age of 26-year-old) as single dose for COVID-19 immunization. The patient medical history was not reported. The patient had no Covid prior vaccination. The patient had no known allergies. Concomitant medication(s) included ascorbic acid, biotin, folic acid, iodine, pantothenic acid, pyridoxine hydrochloride, retinol, vitamin b12 nos, vitamin d nos, vitamin e nos, zinc (CENTRUM MULTIGUMMIES) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccine in four weeks. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number EL3247), via an unspecified route of administration, administered in right Arm on 19Jan2021 10:00 am (at the age of 26-year-old) as single dose for COVID-19 immunization. On 09Feb2021 15:00, the patient experienced soreness at injection site, lethargy. The patient did not receive any treatment for the AE. The patient had not tested Covid post vaccination. Outcome of the events was recovering.  Follow-up attempts are completed. No further information is expected.
Erythemateous edematis, warm to touch right shoulder.  Allergic reaction vs. Dermatitis contact cellulitis.
Dizziness, body aches, chills and high fever over 102 F and also localized reaction redness and swelling at the injection site 10.16 centimeter diameter. Dizziness started 6 hours after vaccination. Temperature was 102.1 by 2 am that day. Took TYLENOL and MOTRIN and fever went away. Fever returned the following day and was 102.8 at 4 pm without analgesic because I was at work. Still ongoing and started taking MOTRIN again. Still having dizziness intermittently and malaise.
After 5 mins of receiving 1 st Pfizer covid vaccine at 10:55am, pt felt nauseous and dizzy. Pharmacist on duty instructed the patient to lay down facing up and started taking his blood pressure every 3 mins while giving the patient the electrolyte Vitamin drink( similar to Gatorade). His blood pressure and pulse readings were 100/60 (60), 93/51 (54), 104/62(68); 101/68(62), 108/79(67),109/79(67). So his blood pressure and pusle went down  for 1 reading then it went back to his normal reading of 109/79 within 10 mins. After laying down for 15 mins and drinking vitamin drink, pt felt better as his nausea/dizziness went away. He felt okay and left the pharmacy at 11:30am. Pt reported no reactions to any vaccines before. His girlfriend called the dad to report the incident and the dad told her that his twin brother experienced the same reaction earlier today when receiving his covid vaccine at another site. His brother felt fine after 30 mins monitoring
The first intradermal attempt did not result in a wheel. The dose was repeated by an expert and the attempt was successful. No physical adverse event occured.
My blood pressure has always been normal. On the Saturday following my shot on Wed. my blood pressure went to 157  over 125  . Felt terrible like (when you bend over and get up to quick) that feeling stayed constant also a feeling of a constant hot flash.  Doctors at ER gave me a through checkup and everything checked out normal  except blood pressure.  They said be sure and notify you because they think it probably was the vaccination.  I am making an appointment with my doctor today .
Vertigo; Dehydration; Vomiting/ throwning up so much; Body aches; Headaches; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VERTIGO (Vertigo), DEHYDRATION (Dehydration), VOMITING (Vomiting/ throwning up so much), MYALGIA (Body aches) and HEADACHE (Headaches) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Addison's disease.   On 23-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VERTIGO (Vertigo), DEHYDRATION (Dehydration), VOMITING (Vomiting/ throwning up so much), MYALGIA (Body aches) and HEADACHE (Headaches). At the time of the report, VERTIGO (Vertigo), DEHYDRATION (Dehydration), VOMITING (Vomiting/ throwning up so much), MYALGIA (Body aches) and HEADACHE (Headaches) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   treatment information provided was Fluids were given No relevant concomitant medications reported.
Fever, Chills, Body Ache, Headache.  Chills lasted about 6 hours.  Body Ache and headache all the next day.
Acute localized lower back pain along with localized lower abdominal pain. Difficult to explain sensations, almost like a catch in lower-mid spine, along with abdominal pain in relatively the same area.   Feels like someone kicked me square in the middle of the spine. Possibly kidney pain? Tends to come in intense waves of pain, with a lingering dull ache seperating the more intense spasms.   The abdominal pain reminds me of a bowel obstruction I had a while back, almost like someone has taken a section of my intestines with both hands and is violently stretching it apart. No diahrrea, or constipation - as far as I can tell.  Lying down or propping and supporting the back does nothing to help with the back pain. Neither does any OTC pain relievers such as Acetaminophen or Naproxen, and as a result sleep is very difficult.
Patient received vaccine that was stored improperly. Vaccine was moved from ultra-cold freezer to freezer on 6/17/21. According to guidance from Pfizer, vaccine stored in the freezer after day 17 is considered improperly stored, and the patient will need to be re-vaccinated.?
Pt received vaccines and walked out to waiting area. Stated to her friend that she didnt feel well so she sat down in the chair shortly after sitting pt began to stiffen backwards in the chair and turn bluish color of face and lips. Very shallow and quick breathing. Pt lost bladder control and her right arm stiffened straight down.
feel sick; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "immunocompromised" (unspecified if ongoing), notes: he was immunocompromised and have diabetes; "diabetes" (unspecified if ongoing), notes: he was immunocompromised and have diabetes. The patient's concomitant medications were not reported. The following information was reported: MALAISE (non-serious), outcome "unknown", described as "feel sick". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a pharmacist concerning two patients who within the last 30 days were vaccinated with ZOSTAVAX (Merck) (subcutaneously, 0.65ml, lot # not reported). On the same day as vaccination the patients had an infection at the injection site. The patients experienced initially redness and swelling at the injection site. The infection had been treated with 2 antimicrobial (unspecified). The pharmacist believed the infection could have been "staph" because of the 2 antimicrobial (unspecified) used and the potency of these antimicrobial (unspecified). The patients had sought medical attention via phone calls. The pharmacist considered the infections to be other important medical events. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available. Follow up information was received from the pharmacist. The pharmacist reported that the patient was administered ZOSTAVAX (Merck) (subcutaneously, 0.65ml) in May 2009. The injection site for ZOSTAVAX (Merck) was red, hot and the "red area grew up the patient's arm". The patient was treated with KEFLEX and BACTRIM. The patient was not hospitalized and the patient recovered. The pharmacist did not consider the patient's reaction to be disabling, life-threatening or serious (previously reported as other important medical event). The pharmacist felt that the patient's reaction to ZOSTAVAX (Merck) was related to the administration technique. This is one of several reports from the same source. Additional information is not expected. This report no longer meets criteria for expedited submission to the FDA, the adverse events are now considered non-serious.