chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fever up to 102.5; nausea; dizziness; muscle aches; joint aches; headache; fatigue; weakness; heart rate racing; injection site pain; This is a spontaneous report from a non-contactable consumer (patient herself). A 47-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EN5318), via an unspecified route of administration (left arm), on 21Jan2021 16:30, at single dose, for covid-19 immunization. The patient has no medical history and has no known allergies. The patient's concomitant medications were not reported. The patient experienced fever up to 102.5, nausea, dizziness, muscle aches, joint aches, headache, fatigue, weakness, heart rate racing, and injection site pain - all on 22Jan2021 02:00. No treatment was received for the events. The patient had not recovered from the events at the time of the report. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not have COVID prior vaccination and have not been COVID tested post vaccination.  No follow-up attempts are possible. No further information is expected.
At  18:45 patient reported development of numbness in back of throat.  Pt. reported no difficulty swallowing.  Patient ate her evening meal without difficulty and symptoms begin to resolve.  Patient took 25 mg of diphenhydramine PO before going to bed. Patient reported no symptoms the next morning.
On day 8 after first dose injection I have a half-dollar sized lump at the injection site that it hard and itchy.
This spontaneous report was received from a 40-year-old male patient, who was reporting on himself. The patient did not receive any concomitant therapies and did not have any pertinent medical history. His concurrent condition included allergy to sulfa. On 01-AUG-2018, the patient was vaccinated with PNEUMOVAX 23 0.5 ml, once, to prevent pneumonia (reported as phemonia) (route of administration reported as injection; lot# and expiration date were not provided). On the same day, also reported as "the day he got the vaccination", the patient started experiencing pain at the injection site, which got worse at an unspecified point in time. The patient did not receive any treatment for the event. There was no laboratory test performed. The outcome of the event was reported as not recovered. Causality assessment was not provided.
Myalgia, SkinRash, Rash, UrticariaPruritus, NauseaVomiting, Arm pain, swelling, pruritus, associated with extreme fatigue, nausea but no vomiting starting at 8 days s/p vaccine, lasting 5 days, resolving spontaneously. Narrative:
no additional AE; the patient was given vaccines after temperature excursion; This spontaneous report was received from a nurse and refers to a 12-month-old male. No information regarding the patient's medical history, concurrent conditions, previous drug reactions or allergies and concomitant medications was provided.  On 10-MAR-2023, the patient was vaccinated with an improper storage doses of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, unk, lot #w021740, expiration date: 10-JUL-2024, administered subcutaneously for prophylaxis on right vasteous lateralis (dose and strength was not provided); pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) lot #W027250, expiration date: 09-JUL-2024, administered intramuscularly for prophylaxis (strength and dose was not provided) left intramuscular; and  measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live recombinant human albumin (M-M-R II) subcutaneous injection, lot #W001519, expiration date: 13-JAN-2024, administered subcutaneously for prophylaxis on left vasteous lateralis  (strength and dose was not provided). Lot numbers and expiration dates were verified to be valid numbers and established the same expiration dates. (Product storage error). No additional adverse event. ; Sender's Comments:  US-009507513-2303USA006990:MSD US-009507513-2303USA007002:MSD US-009507513-2303USA006967:MSD
Tested positive for COVID-19; A spontaneous report  was received from a consumer concerning a 50-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and tested positive for covid-19.  The patient's medical history was not provided. Concomitant medications included garlic, vitamin D3, bupropion hydrochloride, estradiol, progesterone, (ascorbic acid, ergocalciferol, nicotinamide, retinol palmitate, riboflavin, thiamine mononitrate), valacyclovir, useritin, NAC supplement and zinc.  On 18 Jan 2021, approximately five day prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (batch number: 013L2OA) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 22 Jan 2021, the patient tested positive for covid-19. The patient did not receive any treatment.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event tested positive for covid-19 was not reported.; Reporter's Comments: Very limited information regarding the events has been provided at this time.  Further information has been requested.
red rash on arms, trunk, groin 48 hrs p/administration of tetanus vax; given DPH;
Pt called call center on 4/26/21 . Pt got 2nd pfizer vaccine on 4/23/21 and 1st Pfizer on 4/2/21 at site . The night of 4/24/21 pt complains of small lump about 1 inch in size under the armpit of the left arm that is not visible outside but can be felt when touching the armpit and is painful. Pt states the lump gets smaller and less painful and massaging it helps over the days. Pt also states he had pain at the injection site on 4/23/21 but went away. Advised pt to contact PCP to get it checked out in person and provided guidelines regarding vaccine side effects and pt verbalized understanding.
Took Vivotif on days 1,2,3,4; Spontaneous report received on 17DEC2019.  A physician reported that a male consumer "took Vivotif on days 1, 2, 3, and 4" (PT: Inappropriate schedule of product administration), while being on oral Vivotif for typhoid fever prophylaxis. The consumer took the all the four doses of Vivotif on consecutive days (on 13DEC2019, 14DEC2019, 15DEC2019, and 16DEC2019) instead of every other day. Action taken with Vivotif with respect to the reported event was not applicable. The outcome of the reported event was unknown.  Company Comment: A consumer took all four doses of Vivotif on consecutive days instead of every other day (Inappropriate schedule of product administration). Considering the nature of the event, the causality of the event is assessed as not related to Vivotif. ; Sender's Comments: A consumer took all four doses of Vivotif on consecutive days instead of every other day ( Inappropriate schedule of product administration). Considering the nature of the event, the causality of the event is assessed as not related to Vivotif.
Pain and swelling at site of vaccination. Tx Benadryl 12 5/5, po. 9 tid x 2-3 d, Molin 100/5 po, tid 1-2 days.
Full blown chickenpox from head to toe; This case was reported by a physician via sales rep and described the occurrence of chickenpox in a 82-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of rash (1st dose received on 5th December 2020, refer case US2021093359). Concomitant products included COVID-19 MRNA-1273 VACCINE (COVID-19 VACCINE MODERNA) and COVID-19 MRNA-1273 VACCINE (COVID-19 VACCINE MODERNA).   On 26th March 2021, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced chickenpox. On an unknown date, the outcome of the chickenpox was unknown.   It was unknown if the reporter considered the chickenpox to be related to Shingrix.  Additional details were provided as follows:  The age at vaccination was not reported.  The patient received vaccine and experienced full blown chickenpox from head to toe. The patient was seen at the physician's office and that was when the physician learned about the side effects that patient had after 1st dose of vaccine. The reporter did not have information about when the patient was seen at the physician's office. Sales representative was unaware about when the side effects occurred after getting the vaccine and if the side effects was resolved or not and sales representative, physician's office did not know the information about dose, route of administration, site of injection, lot number or expiration date. physician's office did not have detailed information because the patient received the vaccine at the pharmacy. Sales representative did not have additional information about the patient such as demographics or telephone number. The reporter consent to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021093359:Same reporter.
Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: foggy headed-Medium
Pericarditis; A-flutter; Severe night sweats; blood iron decreased; Nightly Chills; A spontaneous report was received from a consumer for a male patient (unspecified age)(reporter father) who experienced atrial flutter, pericarditis, chills and sweats.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On an unspecified date, prior to the onset of the events the patient received second of two planned doses of mRNA-1273 (lot/batch: not provided) intramuscularly for prophylaxis of COVID-19 infection.   On an unspecified date within few hours after receiving the vaccine, the reporter stated that his/her father came down with pericarditis as a vaccination side effect. Three weeks later patient still had it along with nightly chills and severe night sweats. The patient also developed atrial flutter and his iron levels dropped in his blood.   No treatment details were provided.  The seriousness criteria for the event pericarditis was medically significant.  Action taken with mRNA-1273 in response to the events was not applicable.   The outcome of events, pericarditis, chills, and night sweats,  was not resolved.  The outcome of the events, atrial flutter and blood iron decreased, 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 events a causal relationship cannot be excluded. Further information has been requested.
This case was reported by a consumer via call center representative and described the occurrence of chills in a male patient who received SHINGRIX for prophylaxis. On 20th July 2018, the patient received SHINGRIX. In July 2018, less than a day after receiving SHINGRIX, the patient experienced chills, fever and poor sleep. In July 2018, the outcome of the chills, fever and poor sleep were recovered/resolved. It was unknown if the reporter considered the chills, fever and poor sleep to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient's wife. The age at vaccination was not reported. The patient at midnight after receiving the SHINGRIX vaccine experienced chills and a mild fever. These symptoms caused him to not be able to sleep well that night. All symptoms resolved after 7am. The reporter did not consent to follow-up. The reporter was unable to provide additional information. This case was linked with US2019008939, reported by the same reporter.
Patient was transferred from hospital for further evaluation and care by pulmonologist. He started having symptoms a week before with fatigue, emesis, decreased p.o. intake, shortness of breath, vomiting and diarrhea. The two previous takes before death required increasing oxygen and family wanted everything done including intubation. He was transferred to ICU.
runny nose; discomfort in the throat and swollen; discomfort in the throat; Low grade fever after after the first dose and still ongoing; pain in his throat, the fleshy thing in your throat that hags down, has been swollen and remains like that and has pain in the throat; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (runny nose), PHARYNGEAL SWELLING (discomfort in the throat and swollen), OROPHARYNGEAL DISCOMFORT (discomfort in the throat), PYREXIA (Low grade fever after after the first dose and still ongoing) and OROPHARYNGEAL PAIN (pain in his throat, the fleshy thing in your throat that hags down, has been swollen and remains like that and has pain in the throat) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event and Kidney transplant in 2016.   On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 30-Jan-2021, the patient experienced OROPHARYNGEAL PAIN (pain in his throat, the fleshy thing in your throat that hags down, has been swollen and remains like that and has pain in the throat). On 01-Feb-2021, the patient experienced RHINORRHOEA (runny nose), PHARYNGEAL SWELLING (discomfort in the throat and swollen), OROPHARYNGEAL DISCOMFORT (discomfort in the throat) and PYREXIA (Low grade fever after after the first dose and still ongoing). At the time of the report, RHINORRHOEA (runny nose), PHARYNGEAL SWELLING (discomfort in the throat and swollen), OROPHARYNGEAL DISCOMFORT (discomfort in the throat), PYREXIA (Low grade fever after after the first dose and still ongoing) and OROPHARYNGEAL PAIN (pain in his throat, the fleshy thing in your throat that hags down, has been swollen and remains like that and has pain in the throat) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.
The pt experienced pain that night which became progressively swollen and red at the injection site over the next 2 days. Treated with ice. No fever was noted. Symptoms were pretty much going by 3/9/01. The pt developed a head cold on 3/11/01.
Severe edema, erythema, itching, hot to touch from base of neck down to shoulder blade to below the elbow of left arm. Symptoms slowly faded over 5-6 days.
Stomach pain; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (Stomach pain) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ABDOMINAL PAIN UPPER (Stomach pain). At the time of the report, ABDOMINAL PAIN UPPER (Stomach pain) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medication was not provided    Most recent FOLLOW-UP information incorporated above includes: On 16-Jul-2021: Follow up information received, included updates related to outcome of reported events.
Generalized muscle aches/joint pains, fatigue and chills/shivering started on 3/1/18 at around 8pm. Started feeling better on 3/3/18 at noontime.
Patient was administered this above influenza injection on 11/1/2018 before provider and MA administering the vaccine acknolwedged that the patient had already received a flu shot this season on 09/29/2018. No adverse effects were noted and patient was informed of medication error by provider,  PA.
Swelling, tenderness and pain of lymph nodes in shot arm (R) that started on full day 2 with spread to upper and lower armpit nodes over the course of 5 days.  Moderate pain causing immobility.  Of note- this is a booster shot administered approx 7mo after 2nd dose of same vaccine.  This is not a symptom experienced with first or second vaccine.
This spontaneous report was received from a registered nurse refers to an 11 month old patient of unknown gender. No medical history or concurrent conditions were provided. On an unspecified date, the patient was vaccinated with VARIVAX (Merck), subcutaneous route (Dose, strength and lot number not provided). Co-suspect or concomitant therapies were not reported. On an unspecified date, the patient may have received VARIVAX (Merck), two days prior to 12 months of age. No adverse effect was reported. At the time of the report, the outcome of the event was unknown. Additional information has been requested.
Erythematous rash, 5 x 7 cm (L) ARM just below the injection site, Not tender, Not raised.
VACCINE ADMINISTRATION ERROR DUE TO AGE. NO ADVERSE REACTIONS IN CLINIC OR FOLLOW UP CARE
pt recv vax & presented to ER & was dx w/pneumonia;tx w/clavulanic acid potassium salt & amoxicillin trihydrate;pt devel severe case of varicella w/poss liver involvement;also fever, n/v;
shortness of breath; weak cold; not getting the 2nd vaccine; Still not feeling well; shivering; fatigue; weakness; dizziness; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (weakness), DIZZINESS (dizziness), DYSPNOEA (shortness of breath ), FEELING COLD (weak cold) and PRODUCT DOSE OMISSION ISSUE (not getting the 2nd vaccine) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Autoimmune disorder and Graves' disease. Concomitant products included ROSUVASTATIN CALCIUM (CRESTOR) and NIFEDIPINE for an unknown indication.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, the patient experienced ASTHENIA (weakness) and DIZZINESS (dizziness). On an unknown date, the patient experienced DYSPNOEA (shortness of breath ), FEELING COLD (weak cold), PRODUCT DOSE OMISSION ISSUE (not getting the 2nd vaccine), MALAISE (Still not feeling well), CHILLS (shivering) and FATIGUE (fatigue). At the time of the report, ASTHENIA (weakness), DIZZINESS (dizziness), DYSPNOEA (shortness of breath ), FEELING COLD (weak cold), PRODUCT DOSE OMISSION ISSUE (not getting the 2nd vaccine), MALAISE (Still not feeling well), CHILLS (shivering) and FATIGUE (fatigue) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided/unknown.   This case was linked to US-MODERNATX, INC.-MOD-2021-080292 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 19-May-2021: New AE's and other relevant history was added; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-080292:son case
Thrombophlebitis/Phlebitis of lower leg; This is a spontaneous report received from a non-contactable reporter (Consumer). The reporter is the patient.A 46 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 05May2021 10:00 (Batch/Lot number: unknown) at the age of 46 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: THROMBOPHLEBITIS (non-serious) with onset 18May2021 07:00, outcome "recovered" (2021), described as "Thrombophlebitis/Phlebitis of lower leg". The event "thrombophlebitis/phlebitis of lower leg" was evaluated at the physician office visit. Therapeutic measures were taken as a result of thrombophlebitis.Additional information: No other medical history. No known allergies.The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Aspirin treatment received for the adverse event. No hospitalization prolonged. The patient was not diagnosed with COVID-19 prior to vaccination or was not tested for COVID-19 since the vaccination. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
little fever; This is a spontaneous report from a contactable consumer (patient himself). A 41-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EW0196, Expiry date: Unknown), via an unspecified route of administration in Arm Left on 12Jul2021 17:30 (at the age of 41-years-old) as dose 2, single for COVID-19 immunisation. Medical history included Blood pressure high. Patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. No prior vaccinations. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EW0217, Expiry date: Unknown) via an unspecified route of administration in Arm Left on 12Jul2021 17:30 as dose 1, single for COVID-19 immunisation and experienced no adverse event. Concomitant medication included ramipril (RAMIPRIL) taken for hypertension, started three years ago. On 13Jul2021, the patient experienced little fever. He wanted to know the temperature range of the body after receiving dose of the vaccine. Caller stated he know having this little bit of fever is kind of normal. Patient asked, what was the normal range of temperature. Stated the fever began a couple of hours ago today, 13Jul2021. He did not feel bad, just took his temperature and it was 100.5. The patient underwent lab tests and procedures which included temperature: 100.5 on unspecified date. No vaccine administered at Military Facility. The clinical outcome of event was unknown.
Fever, Nausea, Cold, 'the Shakes', Anorexia Worst symptoms from 4 hours after vaccination lasting 24 hours; full duration of symptoms 3 days.
Pt recvd vax 14APR92 & 15APR92 devel a rash on face; No further details were provided;
Pain to (L) shoulder, arm, wrist pain to (L) hip, thigh.
A registered nurse reported that a 4 month old female received Prevnar vaccine and subsequently developed a "high" fever, irritability, inconsolable crying and was not eating. No additional info was available as of the date of this report.
Likey a localized allergic reaction to the vaccination but I cannot exclude possible celluitis. 1)  Prednisone Tab 20mg (Prednisone) .... 3 tab q day x 2 days, then 2 tabs q day x 2 days, 1 tab q day x 2 days. 2)  Keflex Cap 500mg (Cephalexin) .... 2 po bid times per day for 7 days.
Reporting administration error as per Agency.  We contacted Pfizer for expiration dates, pfizer vaccine specialist advised that the expiration dates are deemed viable at the time of vaccine administration. Pfizer vaccine vials only include manufactuarer daes onthe box and vials. Therefore, we contacted pfizer to obtain expirations dates directly from them.  No adverse reaction reported from the patient at the time of vaccination. No adverse reaction reported since the administration of vaccination.
Metallic taste immediately upon receiving dose; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 30Sep2023 at 12:00 as dose 4 (booster), single (Lot number: HH7995) at the age of 52 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: DYSGEUSIA (non-serious) with onset 30Sep2023 at 12:00, outcome "not recovered", described as "Metallic taste immediately upon receiving dose". Therapeutic measures were not taken as a result of dysgeusia.  Additional information: Patient did not receive any other vaccine in four weeks. Patient was not tested for COVID prior or post vaccination. Patient had no known allergies.