chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fever 100.2 F; sore arm; sore muscles (whole body); exhaustion; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 22Mar2021 15:00 (Lot number: EP6955) at the age of 66 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing); "celiac" (unspecified if ongoing); "Hashimoto's" (unspecified if ongoing); "Ulcerative colitis" (unspecified if ongoing); "Known allergy: Pollen" (unspecified if ongoing); "Known allergy: dander" (unspecified if ongoing); "Known allergy: mold" (unspecified if ongoing). Concomitant medication(s) included: ADVAIR; VALSARTAN; NP THYROID. Vaccination history included: Bnt162b2 (Dose number =1,, product=COVID 19, brand: Pfizer, COV-19 Vax, lot number: EN6203, administration time: 15.00, vaccine location = Left arm), administration date: 02Mar2021, when the patient was 66 years old, for COVID-19 Immunization. The following information was reported: PYREXIA (non-serious) with onset 23Mar2021, outcome "recovered" (2021), described as "Fever 100.2 F"; PAIN IN EXTREMITY (non-serious) with onset 23Mar2021, outcome "recovered" (2021), described as "sore arm"; MYALGIA (non-serious) with onset 23Mar2021, outcome "recovered" (2021), described as "sore muscles (whole body)"; FATIGUE (non-serious) with onset 23Mar2021, outcome "recovered" (2021), described as "exhaustion". The patient underwent the following laboratory tests and procedures: body temperature: (23Mar2021) 100.2 Fahrenheit. Therapeutic measures were not taken as a result of pyrexia, pain in extremity, myalgia, fatigue.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The event was not required no prolonged hospitalization. The patient did not have covid prior vaccination and did not test covid post vaccination. Prior to vaccination the patient was not diagnosed with COVID-19 and, since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
pregnant patient was administered Fluzone QIV; Initial information received on 28-Oct-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves an unknown age female patient who was pregnant  and who got  INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV] with no reported adverse event.   The gestation period at onset was not reported. The date of last menstrual period was not reported. The estimated due date was not reported. The actual date of delivery was not reported. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 27-Oct-2022, the patient received a  dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot number not reported via unknown route in the left deltoid for Immunization.    On 27-OCT-2022 the patient developed a non-serious who was pregnant  was administered fluzone qiv (exposure during pregnancy) (same day latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE..  It was reported "The caller mentions that the pregnant patient received the Pfizer Covid-bivalent vaccine on 14Oct2022, A pregnant patient was administered Fluzone QIV from the multi-dose vial yesterday, 27Oct2022 in the left deltoid. The dose was administered by a medical assistant. No other vaccinations were given yesterday to the patient. The patient received the Pfizer bivalent Covid-19 booster vaccine on 14Oct2022.   Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event (pregnant patient was administered Fluzone QIV).  At time of reporting, the outcome was Unknown for the event pregnant patient was administered fluzone qiv. Additionally, at time of reporting, the outcome of the pregnancy is unknown.
pt is 15, but was given the pfizer vaccine by a nurse at clinic . manf and cdc guidelines only allows 16 or older as of. spoke to patient, no adverse effects of any kind. explained what happened and advised to call us back if she experiences any effects out of the norm.
fainted; This is a spontaneous report from a contactable other healthcare professional (HCP) via Pfizer sales representative. This other HCP reported similar events for 2 patients. This is the second of two reports. A female patient of unknown age received the first dose of meningococcal group b rlp2086 (TRUMENBA), via an unspecified route of administration on an unspecified date at single dose for immunization. Concomitant medications and past drug/medical history were not reported. The teenaged patient fainted after the vaccination with meningococcal group b rlp2086 and was taken to urgent care for a follow up. Her parent declined additional doses. The patient's outcome was unknown.  Information about lot/batch number has been requested.; Sender's Comments: A possible causal association between administration of TRUMENBA and the onset of fainted cannot be excluded, considering the plausible temporal relationship and the known adverse event profile of the suspect vaccine.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate. ,Linked Report(s) : US-PFIZER INC-2020459986 same reporter/drug/AE, different patients
20 hours after vaccine  Headache  Muscle Aches   24 hours after vaccine  Fever  Chills Muscle Aches
After immunizations, patient sat approx 10 minutes. Then c/o lightheaded, weakness, diaphoretic and was pale. Patient laid down with cold compress water given. Mother called to room. Mother reports patient has low sodium levels. Patient remains alert. After approx 20mins, pt left with no issues/complaints.
Received Pfizer vaccines on 1/6/21, 1/28/21, Tested positive for COVID by PCR on 7/21/21.
pt recvd vax; inject site Rt arm red;swollen; warm w/ a red line going to medial rt upper arm which is red,warm & swollen; moderate ache in rt arm shoulder; apap helpful;
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: (005570). The reporter is the patient. A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization completed, Manufacturer unknown), for Covid-19 Immunization. The following information was reported: RASH (non-serious), outcome "unknown", described as "I got the booster shot in January ever since I got it I have a severe rash in different parts of my body". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: The patient got the booster shot in January ever since patient got it, had a severe rash in different parts of patient's body was that normal and patient had done various test with Dr. still can't figure out what it could be. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
This case was reported by a physician via sales rep and described the occurrence of injection site hives in a adult male patient who received SHINGRIX for prophylaxis. In July 2018, the patient received SHINGRIX. On an unknown date, 1 day after receiving SHINGRIX, the patient experienced injection site hives and injection site erythema. The patient was treated with Steroids and BENADRYL. On an unknown date, the outcome of the injection site hives and injection site erythema were unknown. It was unknown if the reporter considered the injection site hives and injection site erythema to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported but the patient was in his seventies when he received a dose of SHINGRIX. The physician gave injectable steroid and BENADRYL to the patient.
vial was exposed to room temperature range for 27.5 hours; administration of vaccine from prefilled syringe drawn for more than 12 hours; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administration of vaccine from prefilled syringe drawn for more than 12 hours) and PRODUCT STORAGE ERROR (vial was exposed to room temperature range for 27.5 hours) in a 60-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 037A22B) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Jun-2022 at 10:30 AM, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) .5 milliliter. On 03-Jun-2022 at 10:30 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (administration of vaccine from prefilled syringe drawn for more than 12 hours). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vial was exposed to room temperature range for 27.5 hours). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administration of vaccine from prefilled syringe drawn for more than 12 hours) and PRODUCT STORAGE ERROR (vial was exposed to room temperature range for 27.5 hours) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.   For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication information was provided. It was reported that the patient was administered with an expired vaccine in a prefilled syringe drawn at 7:00am on 02-Jun-2022 was given to patient 03-Jun-2022 at 10:30am. This would have been the patient's first dose. The total amount of time the vial was exposed to room temperature range (8 to 25 degree C= 46 to 77 degree F) was 27.5 hours. The vial did not undergo any temperature excursions. No treatment medication was provided.
This is a spontaneous report obtained from a contactable Health Care Professional through a Pfizer sales representative. The Health Care Professional reported for a patient on behalf of physician. A 61 year old female patient received, on 08Oct2015, intramuscular PREVNAR 13 (Lot. M03211, Expiration date: 31Mar2017, NDC number: 00005197105) 0.5 ml, single dose. The patient received concomitantly Flu vaccine on the opposite arm. Relevant medical history included hypertension. On 09Oct2015, the patient experienced cellulitis. Relevant laboratory data included blood cholesterol on 08Oct2015 (unspecified result). In response to the adverse event treatment was received (BACTRIM 800 mg, tablet). The patient did not recover from the event at time of this report. The adverse event, cellulitis, was considered related to PREVNAR 13.
Pt had flu-like sx and welt on arm.  Took Benadryl.
Swollen lymph node under left armpit; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the arm left on 22Mar2021 at 10:15 (at the age of 53-year-old) as a single dose for COVID-19 immunisation. The patient's medical history included hypothyroidism. The concomitant medications included levothyroxine (MANUFACTURER UNKNOWN) from an unknown start date for an unknown indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient had no allergies to medications, food or other products. The patient did not receive any other vaccines within four weeks prior to the vaccination.  The adverse events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. On 24Mar2021 at 09:00, the patient experienced swollen lymph node under left armpit. The patient did not receive any treatment for the event. The clinical outcome of the event swollen lymph node under left armpit was recovering at the time of report.      No follow-up attempts are needed; information about lot/batch number cannot be obtained.
This spontaneous case, was received on 11-Oct-2017, from other-non-health professional, concerning a 44-year-old adult female patient. The patient's medical history was not reported and the concomitant medications included trazadone, clozapine, LAMICTAL for unknown indications. On 30-Sep-2017, the patient was administered with FLUVIRIN (dose: 0.5 ml, route of administration: intramuscular, anatomical site: right arm, deltoid, batch number, expiration date: not reported). On the same day, the patient experienced constant pain after vaccination. The patient could not sleep due to pain while rolling on right side. The pain intensity was reported as 7/10. At the time of the report, the patient had not recovered. The reporter considered the report as non-serious. Significant case correction received 11-Oct-2017: Coding of the event "[When rolling on right side] she cannot sleep" was corrected to sleep difficult from sleep disturbance.
Medical assistant calling to report a temperature excursion that occurred 8/14/2020 which involved the following products: GARDASIL9, PEDVAXHIB, RECOMBIVAX, ROTATEQ. Per caller, "it would be possible that at least 100 patients have received vaccines; This spontaneous report was received from a medical assistant, concerning a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies or concomitant medications were not reported.  On 31-AUG-2020, the patient was vaccinated with an improperly stored doses of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally as prophylaxis (lot # 1660991 with expiration date 27-APR-2021) (strength and frequency were not reported) and with haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) 0.5 ml as prophylaxis (lot # S036821 with expiration date 21-APR-2022) (strength, frequency, route of administration and anatomical location were not reported).  The improperly stored doses of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) and haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) experienced a temperature excursion of 35.4 Fahrenheit degrees (°F) for the time frame of 20 minutes without previous temperature excursions. It was confirmed that a digital data logger was involved.  This is one of several cases from the same reporter.; Sender's Comments:  US-009507513-2009USA006106:
I am peeling on my torso, my hhighs and calves.  No red rash but I peeling constantly even with dry skin lotions used.  I will give notice to my primary doctor.
Information was received on 10-MAY-2017 from a physician. The physician reported that on an unspecified date, an unspecified patient may have received a dose of one of several improperly stored lots, but she is not sure which one of the lots  the unspecified patient received. The vaccines involved were ROTATEQ lot L038534, expires 18-AUG-2017,  L039638, expires 23-AUG-2017 or L046319, expires 28-SEP-2017. The temperature was reported to be 26 degrees F for 14 hours via data logger. No adverse effects were reported. No other information was reported. Additional information has been requested.
No additional AEs; temperature excursion for VARlVAX; This spontaneous report was received from a nurse referring to an 18-months-old patient of unknown gender. For all the patients, the concurrent conditions, medical history and concomitant medications were not provided.  On 15-SEP-2021, the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX) 1 dose (strength, dose, route, frequency, were not provided) for prophylaxis; Lot No. U010400 has been verified to be a valid lot number for [varicella virus vaccine live (Oka/Merck)], expiration date reported as 01-MAR-2023, and upon internal validation established as the same.  The nurse reported that the vaccine dose was administered on 15-SEP-2021 and there was a temperature excursion for varicella virus vaccine live (Oka/Merck) (VARIVAX). The product experienced an excursion of 4 Celsius degrees (C) from -10 C to 8 C for 20 minutes on 07-SEP-2021 during the transport; and of 4C from -10 C to 8 C for 20 minutes on 09-SEP-2021, again during transport. Previous temperature excursion included from -10°C to 8°C (4C) for 7 hours and 30 minutes. And no adverse events were reported.  This is one of four reports received from the same source.; Sender's Comments:  US-009507513-2109USA005618: US-009507513- 2109USA005639: US-009507513-2109USA005632:
J96.12 CHRONIC HYPERCAPNIC RESPIRATORY FAILURE 5/7/2022 ACUTE RENAL FAILURE, UNSPECIFIED J96.22 ACUTE ON CHRONIC HYPERCAPNIC RESPIRATORY FAILURE 5/7/2022 ACUTE RENAL FAILURE, UNSPECIFIED J96.12 CHRONIC HYPERCAPNIC RESPIRATORY FAILURE 5/7/2022 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED J96.22 ACUTE ON CHRONIC HYPERCAPNIC RESPIRATORY FAILURE 5/7/2022 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED
administered one dose / left outside and was very hot for several hours; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a patient who received HBV (Engerix B adult) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Engerix B adult and Engerix B Pre-Filled Syringe Device. On an unknown date, unknown after receiving Engerix B adult and Engerix B Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: Age at vaccination was not reported. It was reported that the physician administered one dose of Engerix B before without knowing the stability of vaccine. The reporter was unable to confirm if the vaccine was stable when package was retrieved The reporter did not notice the tag alert device had an alarm number. The reporter was concerned about the dose that was administered was it viable.  When the package was retrieved the vaccine left outside and was very hot for several hours, which led to incorrect storage of drug.
Worse than baseline weakness x 1 day, fall (onto grass), could not get up ~3 hours
Itchy rash, discoloration, hardness and hot to the touch; cleared up in 3 days, (used Neosporin pain relief)
Low titers; This case was reported by a pharmacist via call center representative and described the occurrence of therapeutic response decreased in a 19-year-old female patient who received HBV (Engerix B) for prophylaxis.   Co-suspect products included HBV (Engerix B) for prophylaxis and HBV (Engerix B) for prophylaxis.   On an unknown date, the patient received Engerix B at an unknown dose, the 2nd dose of Engerix B and the 3rd dose of Engerix B. On an unknown date, unknown after receiving Engerix B, Engerix B and Engerix B, the patient experienced therapeutic response decreased. On an unknown date, the outcome of the therapeutic response decreased was unknown.   It was unknown if the reporter considered the therapeutic response decreased to be related to Engerix B, Engerix B and Engerix B.  Additional details were provided as follows: The age at vaccination was not reported, however the patient was infant at the time of vaccination series. The pharmacist reported, initial series of Engerix B was administered to the patient at an unknown location in 2000. At the age of 19, the patient was tested and was told that the titers were too low, which led to therapeutic response decreased. The vaccine lot number was not available since the series had not been restarted. The reporter did not consent to follow up.      Lab Comments: Lab test performed on unknown date
Pain on my extremities, unable to hold things with my hands, pain going down my left leg , pain from my neck down my arms, deep depression, strong flare up of my Fibromyalgia and Arthrities together, Severe Headaches and very weak no energy at all and vomiting, nauseated. Dr. stated the shot case a neurological disorder causing the reaction stated above.
Red swollen and hard area around injection site, started two days after vaccine and is still ongoing fatigue headache lasting two days muscle spasms and twitching around injection site swollen lymph nodes in the neck on the same side as injection
Patient complained of dizziness and lower back pain while at home one hour post Shingrix immunization. Patient was going to lay down and drink liquid in case blood pressure got low.
Approximately 11 days after receiving my Moderna booster, I began to start having hives all over my body. They started on my scalp and spread to different parts of my body.   I have been having hives and Dermatographia since May 20th (almost 2 months). I saw an allergist who performed an allergy test on me, and I did not react to anything.
Three days after receiving the vaccine, I started experiencing debilitating cluster migraines. I have experienced these cluster migraines every day, multiple times per day since then. My pain level gets up to a ten out of ten multiple times per day. No medication has worked so far.
Patient experience flu like symptoms and body aches the same evening after receiving vaccine.  On 4/1/21 the patient experienced nausea, high blood pressure, and a headache. Around 7:00 pm that night the patient threw up and became unresponsive. The patient was then transported to the hospital by ambulance. A CT scan showed a brain bleed and the patient was intubated and transferred to another hospital.
This non-serious spontaneous case, initially received on 19-Mar-2018, was reported by other health professional and concerns a 05-year-old, child of an unspecified gender. It was reported that, on an unspecified date, the temperature of the refrigerator in which vaccine was stored dropped to 32 F and was out of range for a total of 1 hour off and on for 2 weeks. On 14-Feb-2018, the patient was administered with FLUCELVAX QIV (dose, route of administration: intramuscular, anatomical location: left deltoid, batch number: 195236, expiry date: 30-May-2018) that was stored out of recommended temperature. The patient had no adverse reactions from the suspect vaccine that underwent temperature excursion. Non-significant follow-up received on 07-May-2018: Upon internal review, it was realised that the expiry date was incorrect. Hence, the expiry date was changed from 31-May-2018 to 30-May-2018 in the product tab. The reporter confirmed that, the patient had no adverse reactions from the suspect vaccine that underwent temperature excursion. Narrative was amended accordingly.