chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from the daughter of a 69 year old female patient. Weight was 170 pounds and height was 61 inches.  The patient had no pertinent medical history and no known allergies.  Concomitant medications included PERCOCET and valacyclovir. On an unspecified date "years ago", the patient received ZOSTAVAX to prevent shingles (route and lot # not provided). The daughter reported that her mother was taken to the Emergency Room (ER) on 22-MAR-2017 because she got the shingles. The patient had a big rash on the waist and had sharp pain in her lower spine inside her body. She also reported her mother has a respiratory infection, chills, fever and sensitive skin. She received treatment for the adverse events. When asked if lab/diagnostic studies were performed, the daughter stated "yes, blood test every year". The outcome of the events was not resolved. The daughter did not provide causality. She stated she was going to reach out to her attorney to take legal action since her mother got the shingles after getting the vaccine. Additional information is not expected as the daughter did not provide consent to contact her mother's physician.
Her attention span has going to nothing; Bad insomnia; I was getting lethargic, I couldn't get all of that like for two weeks; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 02Jul2021 (Lot number: EN6207) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DISTURBANCE IN ATTENTION (non-serious) with onset Jul2021, outcome "unknown", described as "Her attention span has going to nothing"; INSOMNIA (non-serious) with onset Jul2021, outcome "unknown", described as "Bad insomnia"; LETHARGY (non-serious) with onset Jul2021, outcome "unknown", described as "I was getting lethargic, I couldn't get all of that like for two weeks".  Additional information: Reporter seriousness for events: Unspecified. NDC number/UPC number/Expiry Date of COVID-19 Vaccine: Unknown. She just took the shot, two weeks ago and she had bad tremors for like two weeks now. She took this shot, she was getting lethargic, she couldn't get all of that like for two weeks. She took the shot like, around several weeks ago, for the first one. Now she had started getting lethargic and her attention span had going to nothing, when she talked to the reporter she was in bad insomnia. It's gone up for like several weeks and took second shot and they got worse, didn't sleep like sixteen hours a day and a left arm started bad tremors possibly and she got after shot. She believed she got a Pfizer. She got the card, believed one is administered yesterday, received the card from the hospital. She threw her card outside, she believed. It's a Pfizer so, First says the Pfizer and another one at work. She took the Pfizer EN6207 (LOT confirmed) and the second one was EW0173 Pfizer and the first one was administered 02Jul2021 and second one was administered 23Jul2021, confirmed. She probably needed to see a doctor. She started calling the doctor already. She didn't know, she called you guys. She needed to speak to somebody about this, continue like and get worse. Everything has taken five times longer and supposed to, had tremors in her arm from last three five days. He can call doctor an hear in. As reporter hung up the call abruptly. Hence further probing could not be done. Limited information available over the call.  No follow-up attempts are possible. No further information is expected.
Abdominal pain, acute pharyngitis, nausea, viral syndrome, skin reaction. Reported to the Emergency Room within 1 week post vaccination. Amoxicillin 500 mg.
Patient is fully vaccinated.  COVID positive on 4/17/2022 at ED visit. Pt presented to the ED with lightheadedness syncope and a sore throat. Felt lightheaded and passed out several days ago.  Has not done so since.  No chest pain palpitations, some occasional shortness of breath. Positive for fatigue and fever. EKG with SR. Discharged home.
Patient received the vaccine and was experiencing atrial fibrillation; This spontaneous case was reported by a patient and describes the occurrence of ATRIAL FIBRILLATION (Patient received the vaccine and was experiencing atrial fibrillation) in a female patient of an unknown age 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) 1 dosage form. On an unknown date, the patient experienced ATRIAL FIBRILLATION (Patient received the vaccine and was experiencing atrial fibrillation) (seriousness criterion medically significant). At the time of the report, ATRIAL FIBRILLATION (Patient received the vaccine and was experiencing atrial fibrillation) outcome was unknown.            No concomitant medication information was provided.  Patient states she had questions about the new bivalent vaccine.  No treatment medication was provided.  Company Comment: This spontaneous case concerns a female patient of unknown age ,with no medical history reported, who experienced a serious (Medically significant) unexpected AESI of Atrial Fibrillation unspecified days after receiving a dose of mRNA-1273 bivalent BA.4/BA.5. There is no information regarding the patient's age, underlying medical conditions, concomitant medications, diagnostics, clinical course and treatment details have been provided.  The benefit-risk relationship of mRNA-1273 bivalent BA.4/BA.5  is not affected by this report.; Sender's Comments: This spontaneous case concerns a female patient of unknown age ,with no medical history reported, who experienced a serious (Medically significant) unexpected AESI of Atrial Fibrillation unspecified days after receiving a dose of mRNA-1273 bivalent BA.4/BA.5. There is no information regarding the patient's age, underlying medical conditions, concomitant medications, diagnostics, clinical course and treatment details have been provided.  The benefit-risk relationship of mRNA-1273 bivalent BA.4/BA.5  is not affected by this report.
Tested positive for COVID-19; A spontaneous report was received from a consumer who was a 79-years-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced tested positive for COVID-19.  The patient's medical history was not included . Concomitant products was not included.  On 08 Feb 2021, prior to the onset of event the patient received first dose of their two planned doses of mRNA-1273 (Batch No:unknown)intramuscularly in the left arm for prophylaxis of covid 19 infection.  On 09 Feb 2021, the patient experienced tired and breathing labored lasted the whole week. Then got progressively worse. On 16 Feb 2021 she tested positive for COVID-19 and had pneumonia. She was hospitalized for a week.  Treatment information was not included.   Action taken with mRNA-1273 in response to the events was not provided.   The outcome of the events, tested positive for COVID-19 was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event COVID 19 , a causal relationship cannot be excluded.
Information has been received from a physician concerning a 14 year old reportedly healthy female patient with a history of possible TB exposure several years ago in another country, who in 1996, was vaccinated with varicella virus vaccine live (lot # not available). The physician reported that on 5/11/04 the patient had a varicella titer done which came back negative. The physician reported that the patient had been vaccinated at another office. No other information was available. There was no product quality complaint reported. The patient sought unspecified medical attention. Additional information has been requested.
No adverse effects reported; Multiple patients were vaccinated with improperly stored VAQTA; This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. The patient's concurrent conditions and medical history, as well as concomitant medications, were not reported.  On  14-MAY-2019, the patient was vaccinated with an improperly stored dose of hepatitis a vaccine, inactivated (VAQTA) 25/0.5 (units not provided), lot # R018935, expiration date 05-SEP-2019, for prophylaxis (dose, route, anatomical site and frequency were not reported). The reporter stated that the vaccine had a temperature excursion of 34.2 F for 4 hours and 54 minutes, which was detected by a data logger. The vaccine had no previous temperature excursion and there were no adverse effects reported.  This is one of several cases from the same reporter.; Sender's Comments:  US-009507513-1907USA001174: US-009507513-1907USA004852: US-009507513-1907USA004853: US-009507513-1907USA004854: US-009507513-1907USA004855: US-009507513-1907USA004857: US-009507513-1907USA004858: US-009507513-1907USA004859: US-009507513-1907USA004860: US-009507513-1907USA004861: US-009507513-1907USA004862: US-009507513-1907USA004863: US-009507513-1907USA004864: US-009507513-1907USA004865: US-009507513-1907USA004866: US-009507513-1907USA004867: US-009507513-1907USA004868: US-009507513-1907USA004869: US-009507513-1907USA004870: US-009507513-1907USA004871: US-009507513-1907USA004872: US-009507513-1907USA004873: US-009507513-1907USA004874: US-009507513-1907USA004875: US-009507513-1907USA004876: US-009507513-1907USA004877: US-009507513-1907USA004878: US-009507513-1907USA004879: US-009507513-1907USA004880: US-009507513-1907USA004881: US-009507513-1907USA004882: US-009507513-1907USA004883: US-009507513-1907USA004884: US-009507513-1907USA004885: US-009507513-1907USA004886: US-009507513-1907USA004887: US-009507513-1907USA004888: US-009507513-1907USA004889: US-009507513-1907USA004890:
she had no response to the polysaccharide pneumococcal vaccine; Literature report:    This literature marketed report has been received from authors of the literature article entitled as stated above, referring to 78-year-old female patient with a history of common variable immune deficiency (CVID), anti-IgA antibodies, pemphigus vulgaris, allergic rhinitis, asthma, and obstructive sleep apnea presented after vaccination with the Pfizer COVID-19 mRNA vaccine. Her medical history includes an initial diagnosis of Selective IgA deficiency in her 30 s with positive anti-IgA antibodies. In 2004, when she was 61 years old, she started to have an increase in upper respiratory tract and gastrointestinal infections. A repeat immune work up found a global decrease in immunoglobulins with IgG of 444, IgM of 5, and IgA lower than 16.   A vaccine challenge with a pneumococcal polysaccharide vaccine and subsequent challenge with a conjugated pneumococcal vaccine (manufacturer unknown) (strength, dose, frequency, route of administration, lot # and expiration were not reported; as prophylaxis) showed nonresponse with 0 out of 14 titers protective before vaccination, and 0 out of 14 titers protective after vaccination (therapy non-responder).  A copy of the published article is attached as further documentation of the patient's experience.
fever 101.4, chills, shakes, headache, weak.  lasted for 36 hours then I was fine
Patient came in Sunday afternoon with entire arm swollen and unable to bend. She went to ER and got IV BENADRYL and steroids. Said she felt much better.
Started last night, been having sinus problems. Took NyQuil. Had upset stomach.
Swollen Lymph Nodes in Neck and Armpit. Won't go away.
Exactly 8 hours after the vaccine was given, I felt very fatigued, felt cold, had a mild headache, and had sharp, but not debilitating, pain in both the right and left side of my lower abdomen whenever I moved.  The symptoms lasted 24 hours except for the mild headache which is still continuing one week after the vaccine was given.
Patient received  both a second and a third dose in the same arm, same lot on the same day. Patient received both doses back to back by a Dr. who stated that he was tired and distracted and off his routine. Clinic staff called Pfizer and counseled patient based on their recommendations. Clinic staff is calling patient for one week to ascertain whether any other concern or adverse events.
10 days later chest pain numbness of left arm and left leg ,  chest pain was evaluated in eD. Severe malaise and left sided discomfort. seen in ed see below
Patient received vaccines on 2/26/08.  Patient returned to clinic on 2/28/08 with area of induration (1 1/2") and redness at site of varicella vaccine.
The day after vaccine, the patient had fever and felt sick. Through the week the injection site area became red, raised, swollen, and hot to the touch. By 8/31, the raised red area was approximately 3-4 inches in diameter.
sore arm; mild body aches; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE PAIN (sore arm) and MYALGIA (mild body aches) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A /) for COVID-19 vaccination.     No Medical History information was reported.    On 21-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 PAIN (sore arm) and MYALGIA (mild body aches). At the time of the report, VACCINATION SITE PAIN (sore arm) and MYALGIA (mild body aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment information was provided.   This case was linked to MOD-2021-289960 (Patient Link).
Arm was sore, swollen, and warm. Had a little rash around the area.
my period cycle has changed. I took the vaccine on May 6th 2021. The first day of my period was 04/21/21. I also noticed rash under my breasts and also on my face. I also noticed im very itchy.
A few hours after receiving the vaccination, I noticed that food had a metallic taste. I did not lose my sense of taste or my sense of smell; it was only that the sense of taste was altered. The metallic taste had greatly diminished within 24 hours and continued to abate until I was no longer aware of it by 36 hours after injection.
injection site itching; injection site redness; This case was reported by a other health professional via call center representative and described the occurrence of injection site itching in a 81-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In February 2019, the patient received the 1st dose of Shingrix (intramuscular). In February 2019, 1 day after receiving Shingrix, the patient experienced injection site itching and injection site erythema. In February 2019, the outcome of the injection site itching and injection site erythema were recovered/resolved.   It was unknown if the reporter considered the injection site itching and injection site erythema to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, the patient developed injection site itching and redness that resolved in 2 days. The reporter consented to follow up. This case has been linked with case US2019143868, reported by the same reporter.
Left hand tingly/achy/numbness, localized but radiant throughout hand and digits; Left hand tingly/achy/numbness, localized but radiant throughout hand and digits; Left hand tingly/achy/numbness, localized but radiant throughout hand and digits; injection site pain; Mild discomfort (2 of 10), but different than arm/injection site pain; This is a spontaneous report from a contactable other healthcare professional (hcp).  A 31-years-old male patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot EJ1686; 313,121, expiry date not reported) via an unspecified route of administration on 05Jan2021 15:30 at a single dose in the left arm for COVID-19 immunization. Medical history included patient had known allergies to penicillin. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included ibuprofen (ADVIL) at regular dose, 2 pills, one time in 2 weeks. On 05Jan2021 08:00, the patient experienced left hand tingly/achy/numbness, localized but radiant throughout hand and digits, on-and-off throughout day for past 6 days; mild discomfort (2 of 10), but different than arm/injection site pain, which lasted for 2-3 days. The vaccination was done in a hospital. Patient had a nasal swab test post vaccination (COVID-19 Antigen) on 10Jan2021 and the result was negative. No treatments received in response to the events reported. The events were reported as not serious (did not result in death, not life-threatening, did not cause/prolonged hospitalization, not disabling/incapacitating and not a congenital anomaly/birth defect). The events injection site pain and "mild discomfort (2 of 10), but different than arm/injection site pain" were recovered in Jan2021. The outcome of the event "left hand tingly/achy/numbness, localized but radiant throughout hand and digits" was not recovered.
Headache and Dizziness, BP 124/92 HR57 RR20, patient given bottle water and apple juice and felt better. Headache improved, left in stable condition
Patient complains of achy shoulder joint. Arm is sore from about elbow up through neck. Denies any other symptoms. Says soreness started immediately after receiving vaccine. Pain today is no better but no worse.
reactions from booster shot....achy joints, pain at vaccine site (upper arm)...overall achy..had no reaction to either of the actual vaccine shots that I received.  Just the booster
Feel horrible; coughing; headache; fever; This spontaneous case was reported by a patient and describes the occurrence of FEELING ABNORMAL (Feel horrible), COUGH (coughing), HEADACHE (headache) and PYREXIA (fever) in an adult patient of an unknown gender who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.    On 23-Feb-2023, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On 01-Sep-2023, the patient experienced FEELING ABNORMAL (Feel horrible), COUGH (coughing), HEADACHE (headache) and PYREXIA (fever). At the time of the report, FEELING ABNORMAL (Feel horrible) outcome was unknown and COUGH (coughing), HEADACHE (headache) and PYREXIA (fever) had not resolved.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.   For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  It was reported that additional laboratory/diagnostic tests were done, and it was concluded positive. No treatment information was reported.
This spontaneous report received from the pharmacist referred to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 13-DEC-2016, the patient was administered ZOSTAVAX (lot number and expiration date unknown). The pharmacist reported that on 15-DEC-2016, the patient presented with warmth and swelling at the injection site. The symptoms were still present but it was unknown if they have improved. Causality assessment was not reported for the events.  Additional information has been requested.
Vaccine expired on 10/31/22, dose administered to patient on 11/4/22.
Swelling at injection site; This case was reported by a consumer via interactive digital media and described the occurrence of injection site swelling 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 injection site swelling. On an unknown date, the outcome of the injection site swelling was unknown.   It was unknown if the reporter considered the injection site swelling to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 28-NOV-2022 Reporter's Comment: This case was reported by a patient via (Shingrix GSK) interactive digital media. The patient received a dose of Shingles vaccine and experienced swelling at injection site. Additional Supportive Information: Follow-up would not possible as no contact details were available.
Involuntary shudders I had no control over that lasted 4-5 minutes that left me gasping for my breath.   Left arm is quite red and very warm. I was down all day Wednesday &  most of Thursday. It so happened that I had a scheduled appointment with my cardiologist on Thursday and checked ok
soreness arm; itchiness; a rash surround his belly bottom and his; headache; intense fatigue; fever; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (soreness arm), VACCINATION SITE PRURITUS (itchiness), RASH (a rash surround his belly bottom and his), HEADACHE (headache) and FATIGUE (intense fatigue) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031m20a and 025I20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Cardiopulmonary arrest (2years  ago).   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Feb-2021, the patient experienced VACCINATION SITE PAIN (soreness arm), VACCINATION SITE PRURITUS (itchiness), RASH (a rash surround his belly bottom and his), HEADACHE (headache), FATIGUE (intense fatigue) and PYREXIA (fever). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (soreness arm), VACCINATION SITE PRURITUS (itchiness), RASH (a rash surround his belly bottom and his), HEADACHE (headache), FATIGUE (intense fatigue) and PYREXIA (fever) outcome was unknown. Not Provided          Concomitant medication was not provided.  Treatment information reported include Tylenol yesterday twice.
Information has been received from a nurse concerning a 4 year old patient of unknown gender. Information about concurrent condition, concomitant medication and medical history was not provided. On an unknown date the patient was vaccinated with one dose of VARIVAX lot # N008077, expiry date 09-MAR-2019, subcutaneously for prophylaxis, following temperature excursions of -12.3 Celsius degree for 30 minutes and -9.8 Celsius degree for 3 hours 30 minutes (product storage error). A data logger was involved. No adverse effect was report. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1711USA010721: US-009507513-1711USA010722: US-009507513-1711USA010723: US-009507513-1711USA010724: US-009507513-1711USA010725: US-009507513-1711USA010726: US-009507513-1711USA000697: US-009507513-1711USA010728: US-009507513-1711USA010729: US-009507513-1711USA010730:
Narrative: Timing ERROR only, 2nd dose given 68 days after 1st