chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a literature report, Program ID: Unknown for the following literature source(s): "Severe COVID pneumonia and undetectable B cells after vaccination in patients previously treated with rituximab: a case series". A 63-year-old male patient received BNT162b2 (BNT162B2), 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: "former smoker" (unspecified if ongoing), notes: a former smoker (105 pack years); "glomerulonephritis" (unspecified if ongoing); "rheumatoid arthritis" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (hospitalization, medically significant), outcome "unknown", described as "his 2nd dose two and half weeks after 1st dose"; COVID-19 PNEUMONIA (hospitalization, medically significant), outcome "recovering", described as "developed COVID-19 pneumonia". The patient underwent the following laboratory tests and procedures: Body mass index: 45.8. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. Sender's Comments: The reported COVID-19 pneumonia after both the doses of COVID-19 immunization is considered ineffective of BNT162B2, and the Company cannot completely exclude the possible causality between the reported events and BNT162B2 administration.
headache; tiredness; fever; chills; irritating; facial flushing; face turning red; This spontaneous case was reported by a consumer and describes the occurrence of IRRITABILITY (irritating), FLUSHING (facial flushing), ERYTHEMA (face turning red), HEADACHE (headache) and FATIGUE (tiredness) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030B21A and 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included ESTRADIOL (VIVELLE DOT) for an unknown indication.   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1. On 13-Apr-2021, the patient experienced HEADACHE (headache), FATIGUE (tiredness), PYREXIA (fever) and CHILLS (chills). In April 2021, the patient experienced IRRITABILITY (irritating), FLUSHING (facial flushing) and ERYTHEMA (face turning red). In April 2021, HEADACHE (headache), FATIGUE (tiredness), PYREXIA (fever) and CHILLS (chills) had resolved. At the time of the report, IRRITABILITY (irritating), FLUSHING (facial flushing) and ERYTHEMA (face turning red) outcome was unknown.
This is a spontaneous report from a contactable consumer (patient). A 38-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number- EQ0170), via an unspecified route of administration in left arm on 30Apr2021 08:00 (at the age of 38-years-old) as 2nd dose, single for COVID-19 immunization. Medical history included amoxicillin allergy, penicillin allergy and allergy to sulfa drugs. The patient's concomitant medications were not reported. No other vaccine was given in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination has not been tested for COVID-19. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number- EP7533), via an unspecified route of administration in left arm in Apr 2021 08:00 (at the age of 38-years-old) as 1st dose, single for COVID-19 immunization. The patient experienced left arm joint muscle pain at site of injection, moderate, limiting use and full body joint pain in knees, back and ankles, moderate, limiting use on 06May2021 12:00 AM. The events were reported as non-serious. The patient did not receive any treatment for the events. The outcome of the events was not recovered.
Patient reported discernable bump at the site of injection that was red and itchy the night of injection (11/11/22).  The bump moved down the patient's arm during the next few days.  It was no longer red or itchy, but there is a discernable bump on the outside of the patient's elbow on 11-13-22.  Patient reports feeling slightly "off" since receiving the vaccine.
A few hours after receiving the first dose of the Pfizer vaccine, I started getting heart palpitations.  My heart felt like it was beating really hard in my chest, and my pulse rate started fluctuating.  I can feel it in my back when I'm sitting in a chair, I can feel it in my neck, and occasionally in my stomach. My pulse rate would go anywhere from low 90s to over 130. There have been some nights where it was difficult to sleep because it was pounding while lying in bed.  Eating seems to flare it up.  It has been three weeks now since the first dose and I am still experiencing bouts of palpitations.  It has settled some, but still comes and goes.  Pulse rate still fluctuating, but not as high.  I am scared to get the second shot, especially considering people are turning up with heart inflammation now.  I am postponing the second dose.  People keep saying the risk of COVID is worse than potential side effects, but this side effect is quite distressing and is affecting my daily life.  I have found groups online where multiple people complain of the exact same thing after getting the pfizer or moderna vaccine.  The general public needs to be made aware there are other potential side effects rather than "flu-like" symptoms.
pt recv vax 9MAY97 & devel rash on the back & pruritus while in clinic;VS good, BP 88/40, R76, R16;no other sx noted;rash disappeared w/in 15-20min;instructed to DPH
Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Nausea-Medium, Systemic: Vomiting-Medium, Additional Details: Patient informed immunizing pharmacist of \"fear of needles\" before vaccine was administered. Pharmacist talked to patient prior to injecting to distract her. Immediately after puncturing and prior to injecting, pharmacist noticed patient was suddenly triggered, becoming faint and confused. Nausea, vomitting, dizziness and flushing followed. All events happened within 2 minutes post-injection. EMS was called but patient refused to be brought to hospital and called a friend to pick her up.
Within maybe 20-30 minutes of vaccination, I noticed a small dull pain in my right calf;  I disregarded and walked back to the car.  This pain has reduced over the last week, but is still vaguely present.  5-6 hours after vaccination, headache and strong sinus-headache.  Laid down to rest.  I woke up around 20-30 minutes later with full body tremors and muscle spasms.  Muscle spasms particularly violent in my back, feeling similar to if someone was involuntarily using one of those muscle-stimulator elecrode pad systems on  me;  could feel each individual muscle tensing and releasing at random.  Tremors and spasms persisted and then diminished over the next 4-5 hours.   99.7F fever was recorded.   Chills, fever, nightsweats, and repeated sleepless rest/waking every 30-40 minutes until the next day.  Headache was still strong and present at 4am,  took 600mg ibuprofen and continued hydrating.  Headache, general soreness, and fever persisted for ~3 days, but manageable with hydration and rest.  On day 3 a rash appeared on both my knees/innerthigh just above the knee.  Likely not hives, subdermal red speckles that appeared at night;  close to 4mm in diameter, skin was warm to the touch and very itchy.  Most of the rash was gone by morning, and the itching and warmth was completely gone.  I have noticed a very similar rash appear on my front left collar/shoulder area just this morning, but no itch/warmth.  Outcomes: Muscle spasms/tremors subsided within a day. Fever/headache subsided within 3 days Knee/Thigh rash gone. More similar rash just appeared on upper left shoulder/collar. Upper calf dull pain still present, but only barely  "It feels a bit off" would be the best description.
Approximately 8 days post injection, noticed swelling, redness, firmness and itching near injection site.
pt recv vax 4NOV95&18DEC95 the child's baby-sitter devel fever which lasted for 3 days;the babysitter devel a rash;the reporter was unsure if the rash was transmitted from the pt who recv the vax
SWELLING UNDER LEFT ARMPIT.  MOST LIKELY LYMPH NODE SWELLING.
Developed burning hands about 1:00 the next morning after flu shot day before. Got hives/itching to trunk, elbows, butt, back of legs. Took Benadryl and Cimetimine with resolution of symptoms. Symptoms recurred later in day, and 2100 that even. Meds repeated with resolutions of symptoms.
Swollen and very painful lymph nodes in injected arm/ Occasional lymph node pain; Swollen and very painful lymph nodes in injected arm; This is a spontaneous report from a contactable consumer, the patient. A 66-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0181) via an unspecified route of administration in the left arm on 02Jul2021 at 17:15 (at the age of 66-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy related asthma and COVID-19 (Prior to the vaccination, the patient was diagnosed with COVID-19). The patient had known allergies to penicillin, dairy and latex. Concomitant medications included centrum vitamins, linum usitatissimum seed oil (FLAX SEED OIL) and loratadine (CLARITIN ALLERGY) from on an unknown date for unspecified indication and unknown if ongoing. The patient took ibuprofen (MANUFACTURER UNKNOWN) for unknown indication on an unknown date and experienced drug allergy. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. On 03Jul2021 at 17:00, the patient experienced swollen and very painful lymph nodes in injected arm for 4 days. Lessened, but continuous pain for 1 week. Occasional lymph node pain for 3 weeks to date. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. The clinical outcome of event swollen and very painful lymph node was not recovered at the time of this report.
Information has been received from a physician concerning a female who was vaccinated with a third dose of Gardasil.  It was reported that the patient received all three doses in her bottom.  It was reported that the patient experienced sore gluteus muscle after the vaccination in the gluteus muscle.  Physician did not specify which vaccination caused the soreness.  It was unknown whether medical attention was sought.  The patient's outcome was unknown.  No product quality complaint was involved.  Additional information has been requested. 07/08/08 Follow up information indicated that the patient received all 3 doses in the gluteus muscle. The physician did not know whether the patient received adequate dose IM. Additional information has been requested.
pt recvd vax & 21 days p/vax exp tingling in hands & feet & was dx w/GBS; also exp a h/a & elevated BP that day; pt was hospitalized 2 days later; addtl contracted pneumonia;
Could not get comfortable; Could not function; Rash all over her body; Intense neuropathy; Pain in her back to the point she; This spontaneous case was reported by a consumer and describes the occurrence of NEUROPATHY PERIPHERAL (Intense neuropathy) in an 84-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 Neuropathy and Broken hand.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Mar-2021, the patient experienced NEUROPATHY PERIPHERAL (Intense neuropathy) (seriousness criterion medically significant), BACK PAIN (Pain in her back to the point she) and RASH (Rash all over her body). On an unknown date, the patient experienced FEELING ABNORMAL (Could not get comfortable) and IMPAIRED WORK ABILITY (Could not function). At the time of the report, NEUROPATHY PERIPHERAL (Intense neuropathy), BACK PAIN (Pain in her back to the point she), FEELING ABNORMAL (Could not get comfortable), IMPAIRED WORK ABILITY (Could not function) and RASH (Rash all over her body) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. Treatment details included generic Claritin and oxycodone.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
This spontaneous report as received from a pharmacist refers to a 72 year old female patient with allergy to penicillin and allergy to sulfa. On 01-DEC-2014 the patient was vaccinated with PNEUMOVAX 23 (lot # K009874, expiration date 15-MAR-2016, dose and frequency not reported, intramuscularly). No concomitant therapy was reported. On 02-DEC-2014 the patient experienced redness and swelling of her left arm after receiving PNEUMOVAX 23 described as occurring on the opposite side of the arm from the injection site in a subcutaneous area despite the injection being given intramuscularly. The pharmacist additionally reported that the patient could hardly move the arm as a result on 02-DEC-2014. There was no treatment given for the events. The outcomes of the events were reported as not recovered. The patient sought medical attention by an unspecified physician office visit. The relatedness between the events and PNEUMOVAX 23 was not reported. Additional information has been requested.
Within 24 hours I experienced extreme fatigue and it lasted for 3-5 days.  I also noticed my left neck lymph node swelling and having mild pain.  On Sept 11, I noticed one skin lesion on my back waist area.  I took a picture and it looked like a red bug bite.  Not itchy but I could feel it while showering.  On September  17 & 18, while showering, I felt that the spot was rough and a bit larger.  I took a picture and it looks like 3 little pustules.  It is on the same line where I had chicken pox as a kid and also shingles in 1997 at age of 31.
Intermittent hives, treatment with antihistamines and Zantac. Hives started 11/12/17 to 12/4/2017.
This spontaneous report was received from a Registered nurse regarding a 14 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 23-JUN-2017, the patient was vaccinated with improperly stored dose of GARDASIL 9 lot# N004798 with expiration date: 31-OCT-2019 (dosing details and route of administration was not reported) for prophylaxis. No adverse effects were reported. The storage temperature was 47 degrees Fahrenheit to 77 degrees Fahrenheit (49F) and time frame was 14 hours. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint was involved. This is one of the several reports from the same reporter. Sender's Comments: US-009507513-1804USA005153.
Pt came in complaining of pain at injection site. Pt stated is started after flu vaccine on 10/2. Saw specialist on 11/18 who recommended Physical therapy/ nerve block medication and follow up in a few weeks.
sore arm; feeling a little beat up the next day; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 65-year-old male 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. The patient's relevant medical history included: "asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot number: unknown), for COVID-19 immunization, reaction(s): "feeling a little beat up the next day", "sore arm"; Bnt162b2 (DOSE 2, SINGLE; Lot number: unknown), for COVID-19 immunization, reaction(s): "feeling a little beat up the next day", "sore arm"; Bnt162b2;bnt162b2 omi ba.4-5 (DOSE 3 (BOOSTER), SINGLE; Lot number: unknown), for Covid-19 Immunization, reaction(s): "feeling a little beat up the next day", "sore arm". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm"; MALAISE (non-serious), outcome "unknown", described as "feeling a little beat up the next day".  Additional information: The patient had no side effects but only had minor side effects like a sore arm and feeling a little beat up the next day. He had 6 shots of the Pfizer Covid vaccine, two of the initial and 4 boosters.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300289406 Same patient/vaccine, different dose, similar event;
From initial information received on 3/9/05 from a licensed practical nurse regarding an adverse event occurring in the USA, it was reported that a five year old patient (gender not reported) received a dose of DAPTACEL, lot number C1625AA, administered on 3/15/04 as a five year booster dose. The route and site of administration were not reported. Nine months later, in December of 2004, the patient was diagnosed with pertussis. The patient previously received a booster dose of DTaP, lot number 467674, at 15-18 months of age with no reactions reported. It is unknown how many doses the patient received in the past as the child was not a patient at the reporting facility. It is unknown whether the patient recovered from this event. The reporter of this case is the same reporter as case 200500531. (OMIC)
Pt with varicella exposure who was vaccinated with varicella virus vaccine live developed 50-60 generalized lesions of chickenpox with fever of 104F following exposure to wild type chickenpox. Pt experienced very little itch. The pts symptoms occurred within 21 days of exposure.
patient was supposed to receive Menactra vaccine but instead was given Trumenba with no reported adverse event; Initial information received  on 09-Sep-2022 regarding an unsolicited valid Courtesy non-serious case received from partner Pfizer via other health professional.  This case involves a 11 years old female patient who was supposed to receive MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] vaccine but instead was given TRUMENBA with no reported adverse event.  The patient's past medical history, medical treatment(s), concomitant medication, vaccination(s) and family history were not provided.   On an unknown date the patient developed a non-serious event of patient was supposed to receive menactra vaccine but instead was given trumenba (strength, formulation, route, administration site, batch and expiry date was unknown for prophylactic vaccination) with no reported adverse event (wrong product administered) (latency: same day) following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE and (latency: same day) following the administration of TRUMENBA.  Action taken : not applicable.  Outcome: Unknown  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
New onset throbbing migraine headaches with photophobia commencing several hrs after AVA 1 and Typhoid vi. Migraine episodes have continued.
Intermittent shortness of breath, increased resting heart rate, light headedness, chest congestion at rest.  Active heart rate increase of around 10 bpm when performing exercise at same intensity (running same route at same pace).
Extremely warm (hot) at vaccination site. Red, itchy, extreme soreness, swelling. Returned 1-17-14 - given antibiotic - Cephalexin (KEFLEX) 500 mg and Cetirizine (ZYRTEC).
Cold Sores; This case was reported by a consumer via call center representative and described the occurrence of cold sores in a 56-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19th February 2020, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than 4 months after receiving Shingrix, the patient experienced cold sores. The patient was treated with valaciclovir hydrochloride (Valtrex). On an unknown date, the outcome of the cold sores was recovered/resolved.   It was unknown if the reporter considered the cold sores to be related to Shingrix.  Additional information was received as follows: The patient received Shingrix and experienced cold sores. The reporter did not consented for follow up.
This case was reported by a pharmacist and described the occurrence of allergic reaction in a 48-year-old female subject who was vaccinated with FLUARIX (GlaxoSmithKline). On an unspecified date in 2011, the subject received dose of FLUARIX (details unknown). In 2011, at an unspecified time after vaccination with FLUARIX, the subject experienced allergic reaction. Per the reporting pharmacist, the subject came to her pharmacy to request a package insert for FLUARIX. The subject informed the pharmacist that she had an allergic reaction from FLUARIX when she received it last year. The pharmacist did not know if the reaction was local or systemic. Also, the pharmacist did not know where the vaccination occurred. It was unknown if the subject required medical attention. No further information was provided. At the time of reporting the outcome of the event was unspecified.
hive & swelling @ inject site; ice applied; pt observed for approx 45 mins;
Patient experienced hives, on Arms, back, stomach, and upper legs. Large, red, and itchy. Started on 4/12/2021. Pt. came into the clinic to see a provider on 4/13/2021, and still had the hives.
This spontaneous report was received from a pharmacist refers to a 88 hear old female patient with penicillin allergy. The pharmacist reported that the patient was administered a first dose of an unspecified hepatitis B vaccine (manufacturer unknown) on an unknown date in the 1990s and on the same date she developed an itchy rash all over her body. The treatment rendered for event was prednisone (manufacturer unknown). The outcome of itchy rash all over the body was reported as recovered. She sought medical attention - (went to a physician). Additional information has been requested.
This case was reported by a nurse via sales rep and described the occurrence of fatigue in a 55-year-old male patient who received SHINGRIX. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced fatigue, localized erythema and headache. On an unknown date, the outcome of the fatigue, localized erythema and headache were recovered/resolved. It was unknown if the reporter considered the fatigue, localized erythema and headache to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on left deltoid. The patient experienced redness near the mid humerus area only as well as fatigue and headache which lasted a few days. This case has been linked with case US2018GSK064276 and US2018GSK064287 reported by same reporter.