chrisvoncsefalvay/vaers-outcomes huggingface dataset:
LEFT DELTOID EDEMATOUS, ERYTHEMA, AND HOT TO TOUCH. LARGE WELT THAT WAS 1.5X1.5 INCHES.
Pt recvd vax & 48 hrs later devel flu-like sx, t103, nausea & vomiting; events have subsided;
Pt came in for Pfizer Booster. After administration pt asked for a glass of water. When returning with glass of water, pt's girlfriend, was yelling for help. Upon entering room pt was in chair convulsing, clammy and noted color change. Pt was breathing and able to answer questions. Alerted MA to get provider. While in room convulsing lasted for 10-15 seconds. BP was 122/76, HR 84 and PO 99. Provider assessed pt and requested glucose reading. Glucose reading 106. Juice and snacks provided. Pt advised to wait in office for 30 minutes. Continued 5 minute checks on pt. Pt alert and oriented. After 30 minutes assessed by provider. Pt continued to be free of symptoms and feeling better, pt then left office.
Information had been initially received from a female consumer concerning her 70 year old father who she reported that on an unspecified date in 10/00 was vaccinated in his arm with pneumococcal vaccine 23 polyvalent (dosage, specific site, route and lot number not provided). In 10/00, almost immediately,post vax, the pt experienced pain in his arm. It was indicated that the pt had sought medical attention and subsequently the pt still has experienced pain in his arm. In follow-up, the pt's physician reported that a 70 year old white retired male had been vaccinated on 10/23/00, IM, 1st dose, with an influenza virus vaccine (dosage and specific site not reported, vaccine manufacturer was reported as "Medeva", lot number E65630HA). On 11/7/00, the pt was vaccinated with a 1st dose of pneumococcal vaccine 23 polyvalent, IM (dosage and specific site not reported; lot number reported as 637094/0945K). On 7/14/01, the pt developed back pain, generalized body aches and acute renal failure. At the time, the pt was hospitalized and dx'd with Wegener's granulomatosis. On 8/1/01, the pt recovered. No further information was available.
A few hours after receiving the vaccine, my heart started racing strongly. I had to lay down and take very deep breaths. This lasted about an hour. About a week later, it happened again. Another week later, again. Two weeks later, again. Two weeks after that, again. This is where I'm at now. I'm unsure if it will continue every couple of weeks, but this is abnormal and did not start until after the 2nd dose of the Phizer Covid-19 Vaccination.
body aches; chills; went to bed and felt extremely hot; was "drained of energy" for the next couple of days / has no energy; "couldn't get warm enough" and that he's "still cold"; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 62 year-old male patient received bnt162b2 (BNT162B2), administration date 22Feb2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st Dose), for Covid-19 Immunisation. The following information was reported: PAIN (non-serious), outcome "recovered", described as "body aches"; CHILLS (non-serious), outcome "recovered", described as "chills"; ASTHENIA (non-serious) with onset 03Mar2021, outcome "unknown", described as "was "drained of energy" for the next couple of days / has no energy"; FEELING COLD (non-serious) with onset 03Mar2021, outcome "unknown", described as ""couldn't get warm enough" and that he's "still cold""; FEELING HOT (non-serious), outcome "unknown", described as "went to bed and felt extremely hot".  Additional Information: The patient experienced body aches and chills following both doses, duration after first dose was 2-3 days and second dose was 2 days before resolving. After the second dose body aches and chills resolved, he stated his was "drained of energy" for the next couple of days. He now reports that yesterday afternoon (03Mar2021) he "couldn't get warm enough" and that he's "still cold" and has no energy. He "went to bed and felt extremely hot" but didn't take his temperature. The patient wanted to know whether this is from the vaccine, or it was common for symptoms to recur. The patient also reported that he commonly has reactions to vaccination, siting that last year after he received his Shingles vaccines he "felt horrible after". The patient haven't been around anyone, no energy. Felt horrible after both doses of shingles. The patient wore two masks, excellent filter in my personal mask, stayed outside.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This case was reported by a consumer and described the occurrence of hepatitis A antibody titer positive in a 20-year-old female subject who was vaccinated with Hep A vaccine (manufacturer unspecified).  A physician or other health care professional has not verified this report.  On 16 January 2007 the subject received unspecified dose of Hep A vaccine (unknown).  On 21 February 2007, 36 days after vaccination with Hep A vaccine, the subject experienced hepatitis A antibody titer positive.  At the time of reporting the outcome of the event was unspecified.
The following symptoms occurred 12-36 hours after covid-19 vaccine dose: Light sensitivity, severe migraine, increased urine output, decreased water intake (couldn?t pick up the bottle of water, severe muscle weakness & pain, nauseated, lethargy, skin sensitivity (could touch my skin and wanted to cry when sheets touched my skin), loss of appetite.  26-30 days after dose I had a series of migraines.  I have only ever had one other headache in my life that I would consider a migraine.  I was sensitive to light and nauseous from the pain.
Patient received vaccine on 1/2 (Sat) and today went to the ED 1/5. On Sunday am began vomiting and diarrhea with no blood in stool or emesis. Denies fever. States he only coughs post vomiting and it is un productive. Pt has been urinating and has been able to keep food and fluids down. Noted with skin warm and dry/resps, NAD and color WNL. Pt denies any abdo pain except post vomiting. SARs CoV2 RNA test negative.
Information has been received from the authors in a published literature article and refers to a 12 year old male patient. The patients' concurrent conditions included Common variable immune deficiency (CVID), low immunoglobulin M (IgM), elevated immunoglobulin A (IgA), and normal immunoglobulin G (IgG). On an unspecified date, the patient was vaccinated with PNEUMOVAX 23 (dose, frequency, anatomical location, lot number and expiration date were not reported) and with unspecified influenza and measles vaccines,  but he showed poor response to the vaccines (Vaccination failure). Thereafter, the patient was placed on treatment with intravenous (IV) Immunoglobulin therapy due to low immunoglobulin M (IgM), elevated immunoglobulin A (IgA), and normal immunoglobulin G (IgG) but poor response to the vaccines. The outcome of vaccination failure was unknown at the time of the report.
received her third dose of Cominarty approximately 6 and half months after primary series; received her third dose of Cominarty approximately 6 and half months after primary series; severe pain and swollen lymph nodes by her breast and under her arm pit; severe pain and swollen lymph nodes by her breast and under her arm pit; This is a spontaneous report from a contactable consumer or other non hcp. A 44-years-old female patient received third dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as DOSE 3, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient previously received first dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: not reported) via unspecified route of administration on unspecified date as DOSE 1, SINGLE for covid-19 immunisation. Patient previously received second dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: not reported) via unspecified route of administration on unspecified as DOSE 2, SINGLE for covid-19 immunisation. The patient experienced received her third dose of Comirnaty approximately 6 and half months after primary series on an unspecified date, received her third dose of Comirnaty approximately 6 and half months after primary series on an unspecified date, severe pain and swollen lymph nodes by her breast and under her arm pit on an unspecified date. The outcome of the events off label use, extra dose administered, axillary pain, lymphadenopathy was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
After approximately 8 hours, initially very lethargic and expected left arm pain at injection site. A few hours later developed Severe headache, light headedness nearly fainting, motion sickness, mild cough, general fogginess, tingling of head (possibly nerves  & related to severe headache ). Left arm pain & lethargy are not active.
Narrative:  Fully vaccinated patient admitted for infected/necrotic foot wound found to be COVID positive incidentally
My husband got sick starting on 08/02/2021 and on 08/05/2021 he had to leave work because he was not feeling good. He got tested on 08/06/2021 for Covid. It came back positive. I got sick on 08/07/2021. I had night sweats, headache, and sore throat. I got a Covid test in 08/09/20/2021. I went to urgent care on 08/10/2021 at hospital because I was feeling so bad. They tested me for Covid and my test came back negative but I had all the symptoms. They did a ton of blood work, x-ray of my lungs, flu test, and test for other respiratory viruses. I saw my PCP afterwards on 08/17/2021 and she said that with all the symptoms I must have had Covid and I just tested too early. She said the vaccine saved us from having to go to the hospital. We think we got Covid 2 weeks before. When I went to see my doctor, she said I was looking fine and my lungs sounded fine. She thinks I might have a mild case of Covid or something else. 4 or 5 days later I was doing better. I was tired for about a week. But overall, I was fine.
Initial and follow up information has been received from a registered nurse concerning a 15 year old female with no pertinent medical history who on 23-FEB-2007 was vaccinated IM in her right arm with 0.5 ml, first dose of GARDASIL vaccine (lot # 656049/0187U). There was no concomitant medications. On 23-FEB-2007 the patient experienced initial stinging that turned into muscle soreness. There were no laboratory or diagnostic tests performed. Unspecified medical attention was sought. As of 30-APR-2007, the patient's initial stinging and muscle soreness persisted. Additional information has been requested.  This is in follow-up to report (s) previously submitted on 5/14/2007. Additional information not expected.
after receiving inj. pt sat down and passed out in waiting room. Out for approx 45sec, pt taken to treatment room here in clinic and seen by attending dr; was given iv fluids and recovered. Pt did loose bladder control. Pt stated she has passed out from imms before.
MILD SIDE EFFECTS; This spontaneous report received from a patient by a Business partner (Pfizer Inc.) on 18-JUN-2021 was received on 18-JUN-2021 and concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the subject experienced mild side effects. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of mild side effects was not reported. This report was non-serious.
Erythema, induration at the site of injection with warmth and pain. She did have tingling in her tongue for a few hours. Antibiotics given.
Severe Left shoulder pain; Initial information received on 27-Mar-2020 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 62 years old female patient who experienced severe left shoulder pain (musculoskeletal pain), while she received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's medical history, past medical treatment, vaccination and family history were not provided.  Concomitant medications included VARICELLA ZOSTER VACCINE (VARICELLA ZOSTER VACCINE) for Immunisation.  On 12-May-2019, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot: UT6713NA) via an intramuscular route in the left deltoid for prophylactic vaccintion.  On an unknown date (few days after vaccination), the patient developed a non-serious severe left shoulder pain (musculoskeletal pain) (Unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  Final diagnosis was musculoskeletal pain.   It was not reported if the patient received any corrective treatment.  The patient recovered after few months.
At 6 days - numbness, tingling in feet, weakness (L) hip extensor muscle, then clumsy (L) hand, (R) hip weakness, L-1 numbness (saddle numbness) couldn't feel urine stream. Peaked at 7 days. At 21 days noted heat sensation in legs. Sxs slowly resolving.
Itching Injection Site; Hurting Injection Site; Tender to the touch Injection Site; Sneezing; sore left arm; Flu like Symptoms; coughing; High Blood Sugar (>200 mg/dL); Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore left arm), INFLUENZA LIKE ILLNESS (Flu like Symptoms), COUGH (coughing), BLOOD GLUCOSE INCREASED (High Blood Sugar (>200 mg/dL)) and FATIGUE (Fatigue) in a 71-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.     The patient's past medical history included Hypertension.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore left arm), INFLUENZA LIKE ILLNESS (Flu like Symptoms), COUGH (coughing), BLOOD GLUCOSE INCREASED (High Blood Sugar (>200 mg/dL)), FATIGUE (Fatigue) and SNEEZING (Sneezing). On 20-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (Itching Injection Site), VACCINATION SITE PAIN (Hurting Injection Site) and VACCINATION SITE WARMTH (Tender to the touch Injection Site). On 12-Feb-2021, PAIN IN EXTREMITY (sore left arm), INFLUENZA LIKE ILLNESS (Flu like Symptoms), COUGH (coughing), BLOOD GLUCOSE INCREASED (High Blood Sugar (>200 mg/dL)) and SNEEZING (Sneezing) had resolved. At the time of the report, FATIGUE (Fatigue), VACCINATION SITE PRURITUS (Itching Injection Site), VACCINATION SITE PAIN (Hurting Injection Site) and VACCINATION SITE WARMTH (Tender to the touch Injection Site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Temp 100.6, Achy muscles and joints, headache, fatigue, weakness
Pt developed itching in hands and feet approx 36 hrs after flu vaccine adminitration. These progressed to hives and pt also had a dry cough/chest pain10/16/2009 received hospital records for 10/2-10/3/2009. Patient reporting sx 4 days post vaccine of itching, rash, welts, swelling in fingers and arthralgias. Tx: IV Solu Medrol, IV Benadryl and IV Famotidine. DC DX urticaria.
Rash on chest back and face lasting about 5-7 days  This was the 2nd dose of the vaccine
pt recv vax 28AUG97 & a pregnancy test was positive on 10SEP97 (LMP 7AUG97);expected date of delivery was 14MAY98;15SEP97 had miscarriage;
Anaphylaxis reaction; A spontaneous report was received from a nurse concerning her co-worker, a 28 year-old female patient, who received Moderna's COVID-19 Vaccine and experienced anaphylaxis reaction.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 23 Dec 2020, prior to the onset of the event, the patient received the first of two planned doses of mRNA-1273 for prophylaxis of COVID-19 infection.  On 23 Dec 2020, within five minutes of vaccine administration, the patient experienced anaphylaxis reaction. The patient had symptoms of throat tightness, dizziness, nausea, weakness, and increased heart rate. Treatment for the event included an epinephrine pen  On 29 Dec 2020, the nurse reported that the patient was still having some of the symptoms, including dizziness, nausea, and weakness.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the event, anaphylaxis reaction, was considered not resolved.  The reporter assessed the event, anaphylaxis reaction, as related to Moderna's COVID-19 Vaccine.; Reporter's Comments: This case concerns a 28 year old female patient, who experienced a serious unexpected event of anaphylactic reaction. The event occurred apparently 5 min after first dose of mRNA-1273 (Lot# unknown) vaccine administration. She was treated with epinephrine pen. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Patient was given Moderna COVID vaccine. Patient was 15 year old at time of injection. Moderna is not indicated for persons under the age of 18 at this time.  No current symptoms.
Vaccines administered Thursday 12/27/12. Client states reaction noticed Saturday morning 12/29/12. States "itching, 10 cm redness / swelling, & taut skin" around Zoster injection site. States "improving" Monday 12/31/12.
pt recv vax & devel an inj site rxn characterized by redness & swelling, w/pain radiating from site down the arm;pt has recv pneumococcal vax in the past;this is one of ten patients who exp above rxn p/vax;
This spontaneous report was received from a health care worker (Medical Assistant) refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 15-JUL-2016, the patient was vaccinated with first dose of RECOMBIVAX HB (lot # L042846, expiry date 15-SEP-2017, dose, vaccination site, route not provided). On 25-AUG-2016, the patient received second dose of RECOMBIVAX HB (lot # M007763, expiry date 15-SEP-2017, dose, vaccination site, route not provided). On 09-SEP-2016, the patient was inadvertently received third dose of RECOMBIVAX HB (lot # M007763, expiry date 15-SEP-2017, dose, vaccination site, route not provided). No adverse effects were reported. Product quality complaint (PQC) was not involved. No additional information was provided. Additional information has been requested.
Pain left upper arm and increasing redness; felt with chills; no streaks from site; no fever; no tenderness - on physical exam 18 cm x 15 cm erythema almost completely circumferential of left upper arm inferior to 2 injection sites nontender. Treated empirically with Cephalexin 250 mg oral capsule .... 1 cap 3 times a day.
A non-serious spontaneous report of expired FLUMIST given was received from a company sales representative concerning a 47-month-old male. On 23-Feb-2009, a Medical Assistant on a Student Health campus inadvertently administered expired FLUMIST to a child. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, the event is considered resolved. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. This is in follow-up to report(s) previously submitted on 03/02/2009. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from the previous season and 2) product expiring during the peak of the flu season resulting in some medication errors that occurred shortly after the product expired. Follow-up received on 06-Apr-2009 includes: this was patient's first dose of FLUMIST; country where the office is located and no adverse events were reported. Follow-up information was received on 09-Apr-2009: Product Complaint Investigation results.
Patient received 0.25ml of Moderna bivalent vaccine; No adverse Event; This spontaneous case was reported by a nurse and describes the occurrence of UNDERDOSE (Patient received 0.25ml of Moderna bivalent vaccine) and NO ADVERSE EVENT (No adverse Event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     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) .25 milliliter. On an unknown date, the patient experienced UNDERDOSE (Patient received 0.25ml of Moderna bivalent vaccine) and NO ADVERSE EVENT (No adverse Event). At the time of the report, UNDERDOSE (Patient received 0.25ml of Moderna bivalent vaccine) and NO ADVERSE EVENT (No adverse Event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse Event) to be not related. No further causality assessment was provided for UNDERDOSE (Patient received 0.25ml of Moderna bivalent vaccine).    No concomitant drug information was provided.  It was reported that 196 patients had received 0.25 ml of Bivalent Moderna vaccine.   It was unknown if the patient had received any other vaccine 4 weeks prior to COVID-19 vaccine.  No treatment drug information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 27-Dec-2022: Live follow up received age group, narrative updated.
This spontaneous report was received from a pharmacist and refers to an unspecified number of patients of unknown age and gender. No information about the patients' pertinent medical history, drug reactions, allergies and concomitant therapies was provided. On unknown dates, the patients might have been vaccinated with improperly stored doses of PROQUAD injection (dose, route of administration, lot number and expiration date were not reported). The vaccine was stored in the refrigerator at an unknown temperature for an unknown amount of time. It was unknown if any doses had been administered. The sterile diluent (MERCK STERILE DILUENT) used for reconstitution of potentially administered vaccines did not undergo an excursion. No adverse effects were reported. There was no product quality complaint involved in this case. Additional information has been requested.
Started with tenderness  at injection site within an hour,  then swelling started around injection site about 8-9 hours later,  then redness, itchiness and welt ( welt felt feverish)  developed running down my arm towards inner elbow next morning about 22-24 hours after injection.  Welt lasted for about 3 days but redness and itchiness lasted for  10-12 days.
head congestion, sore throat, dry eyes, dry nose; injection site red, raised on 1/8/21 Narrative: Employee reports COVID exposure from coworker same week, sent for test, no result documented at this time.