chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient reports 10 days of high BP, tachycardia, anxiety, stomach ache, difficulty breathing following first dose of Pfizer vaccine. Per patient, the patient's doctor stated this reaction was likely anxiety-induced. Patient reports also having a rash a week later, which was resolved by Benadryl. Patient's doctor recommended second dose of Pfizer and patient requested to receive second dose despite reaction.
This spontaneous report was received on 08-MAY-2017 from a licensed practical nurse and refers to a 6 month old infant, gender unknown. There was no information about the patient's concurrent conditions, concomitant therapy or medical history provided. On 19-SEP-2016, the 6 month old infant received vaccination with an improperly stored dose of ROTATEQ (lot # L046319, expiration date: 28-SEP-2017, dose was not reported), orally. No symptoms were reported. The administered dose of vaccine experienced the temperature excursion of 32 degrees Fahrenheit for 15 minutes and 31 degrees Fahrenheit for 15 minutes. Data logger was involved. There were no previous excursions reported. The licensed practical nurse stated they did not know why the temperature excursions occurred but there were no further excursions. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1608USA012908: US-009507513-1608USA012916: US-009507513-1705USA004952: US-009507513-1705USA004967: US-009507513-1705USA004960: US-009507513-1705USA004965: US-009507513-1705USA004973: US-009507513-1608USA012794: US-009507513-1705USA004961: US-009507513-1705USA004962: US-009507513-1705USA004942: US-009507513-1705USA004944: US-009507513-1705USA004945: US-009507513-1705USA004947: US-009507513-1705USA004948: US-009507513-1705USA004949: US-009507513-1705USA004950: US-009507513-1705USA004951: US-009507513-1705USA004953: US-009507513-1705USA004954: US-009507513-1705USA004955: US-009507513-1705USA004946: US-009507513-1705USA004956: US-009507513-1705USA004957: US-009507513-1705USA004958: US-009507513-1705USA004959: US-009507513-1705USA004964: US-009507513-1705USA004966: US-009507513-1705USA004968: US-009507513-1705USA004969: US-009507513-1705USA004970: US-009507513-1705USA004971: US-009507513-1705USA004972: US-009507513-1705USA004974: US-009507513-1705USA004975: US-009507513-1705USA004976: US-009507513-1705USA004977: US-009507513-1705USA004978: US-009507513-1705USA004979: US-009507513-1705USA004980: US-009507513-1705USA004981: US-009507513-1705USA004982: US-009507513-1705USA004983: US-009507513-1705USA004984: US-009507513-1705USA004985: US-009507513-1705USA005004: US-009507513-1705USA005005: VAQTA; US-009507513-1705USA005006: US-009507513-1705USA005007: US-009507513-1608USA012916: US-009507513-1608USA012908: VAQTA; US-009507513-1705USA004887: US-009507513-1705USA004888: RECOMBIVAX HB; US-009507513-1705USA004889: US-009507513-1705USA004890: RECOMBIVAX HB; US-009507513-1705USA004891: RECOMBIVAX HB; US-009507513-1705USA004892: RECOMBIVAX HB; US-009507513-1705USA004893: RECOMBIVAX HB; US-009507513-1705USA004894: RECOMBIVAX HB; US-009507513-1705USA004895: RECOMBIVAX HB; US-009507513-1705USA004896: RECOMBIVAX HB; US-009507513-1705USA004897: RECOMBIVAX HB; US-009507513-1705USA004898: RECOMBIVAX HB; US-009507513-1705USA004899: RECOMBIVAX HB.
Pt vaccinated with Engerix-B head feeling funny, pounding feeling bilateral neck, BP elevated.
11:30 face started to itch; 2:00 pm Stomach upset & fever; 6:00 pm Legs itching, throat swelling; 12:00 am Painful, itching, trouble breathing. Was seen at 12:30 am, Triage Nurse told to take Benadryl.
21OCT pt recvd vax; noc sore throat "fire red", swollen neck glands-swollen ax glands, low grade fever 1 wk, green-yellow as drainage-bronchial; ER MD dx as flu vax rxn;
24 hrs p/vax pt exp a temp of 100.4, very painful arm & chest pain; pt was treated @ home w/APAP & cool compresses & sx resolved w/in the next 1-2 hrs;
ST started 28Jan2023 after daughter's school had an outbreak; ST started 28Jan2023 after daughter's school had an outbreak; This is a spontaneous report received from a non-contactable reporter(s) (Nurse) from product quality group.  A 48-year-old female patient received BNT162b2 (BNT162B2), on 03Mar2021 as dose 1, single (Lot number: EL3247), on 24Mar2021 as dose 2, single (Lot number: EL3247) and on 17Dec2021 as dose 3 (booster), single (Lot number: FF2589) at the age of 47 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 28Jan2023, outcome "unknown", COVID-19 (medically significant) with onset 28Jan2023, outcome "unknown" and all described as "ST started 28Jan2023 after daughter's school had an outbreak". The event "st started 28jan2023 after daughter's school had an outbreak" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (28Jan2023) Positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of drug ineffective, covid-19.  Clinical course: ST started 28Jan2023 after daughter's school had an outbreak. Unknown if COVID prior vaccination. Tested for COVID post vaccination. COVID test post vaccination- Home AG: Nasal Swab  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events VACCINATION FAILURE and COVID-19 and BNT162B2.
rt arm (Td) deep aching pain traveled down to rt calf;unable to move arm & difficult to walk;sxs started 24hrs p/vax; sxs resolving as of 16NOV95
pt recvd vax then fainted,rested in clinic but fainted again at home;to clinic again, MD said was physiological response to inject;
Tired Muscle aches  Exhaustion one week after can?t get out of bed  Headache
Almost immediately after vaccine she had swelling and pain which is a common side effect.  But later on that day/night she experienced pain and passed out in her hallway and hit her head and elbow and needs to get xrays.
2 days p/vax pt hosp for IV ATB due to pain, redness, swelling & bullae lt arm, fever;
Fatigue; nausea; stomach ache; malaise; post-nasal drip; This is a spontaneous report from a contactable healthcare professional.  A 30-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), intramuscularly in the left arm on 17Dec2020 15:00 at a single dose for COVID-19 immunization.  Medical history included COVID-19 (prior to vaccination).  Concomitant medication included sulfamethoxazole, trimethoprim (BACTRIM) and escitalopram (MANUFACTURER UNKNOWN).  The patient had no known allergies or other medical history. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  On 18Dec2020 03:00, the patient experienced fatigue, nausea, stomach ache, malaise and post-nasal drip.  No treatment was received for the events.  The outcome of the events was recovering.    The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
Fainting; This is a spontaneous report from a non-contactable consumer (patient). This consumer reported similar events for 02 patient. This is the 1st of 2 reports. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 23Dec2020 at single dose for COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced fainting on 31Dec2020. The patient went to the emergency department in regards to fainting and was told the fainting couldn't be related to the COVID-19 Vaccine. Then she heard about someone else fainting. Outcome of the event was unknown.  No follow-up attempts are possible, information about lot/batch cannot be obtained. No further information is expected; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021006463 same reporter/drug/event, different patient
Received shots - Menactra/Varivax and within 24 hours bone achiness general malaise and headache and low grade fever. Redness on R arm and R sternum area also redness on L arm but no distal to it
4 DAYS AFTER VAX, DEVELOPED ACHING IN JOINTS (KNEES, SHOULDERS, HANDS- WHOLE BODY) AND STIFFNESS IN JOINTS. THOUGHT FLU BUT NO OTHER SYMPTOMS. NO MEDS. BEDREST. PT STILL EXP SOME PAIN.
Sore throat, extreme fatigue first three days, developed into chest infection, coughing, persistent extreme fatigue. Slight sore muscles. Attempt at physical activity caused near collapse from nausea, and chest pain around heart.
This spontaneous report as received from a medical assistant refers to an unspecified number of patients (age and gender unknown). On unkown dates the patients were vaccinated with improperly stored PNEUMOVAX 23 dose, route of administration and lot# were not reported. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Exactly 4 hrs after shot, patient had heart palpitations, respiratory distress and elevated blood pressure. Was treated at ER with IV prednisone, BENADRYL & PEPCID.
I had severe joint pains throughout my body, fever, chills, muscle spasms in my shoulders, and a headache. I went to work, but had to leave early to go home and sleep. Today, 12/7/2018, I am back at work -- feeling better, but still have symptoms. They are at least manageable today, though.
fever; body chills; bad headache; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 62-year-old female patient received BNT162b2 (BNT162B2), as dose 4 (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: BNT162b2 (Dose:01), administration date: 26Mar2021, when the patient was 60-year-old, for Covid-19 Immunization; BNT162b2 (Dose:02), administration date: 16Apr2021, when the patient was 60-year-old, for Covid-19 Immunization; BNT162b2 (Dose:03), administration date: 23Mar2022, when the patient was 61-year-old, for Covid-19 Immunization. The following information was reported: PYREXIA (non-serious), outcome "not recovered", described as "fever"; CHILLS (non-serious), outcome "not recovered", described as "body chills"; HEADACHE (non-serious), outcome "not recovered", described as "bad headache".  Additional information: Do the other shots have vomiting. I didn't get it with the other shots, I didn't get it with the other ones. Is vomiting directly related to the new variant vaccine? Pt had 4 previous PFizer covid vaccines and boosters. She states that she did work for Pfizer from 2001-2014. Patient is a 62 year old female. Per caller: 'I got kinda crappy for day or two fever, body chills, bad headache. Caller states, "Hopefully I have now experienced all the symptoms of all the shots and next time I wont have them".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201193681 same patient, different dose/event;
After receiving Covid vaccine, employee experienced lightheadedness, palpitations, and throat tightness. VS: BP 147/94, HR 112, spo2 100%. She was given water and snacks. Repeat VS: BP 128/90, HR 85, spo2 99%. After waiting longer, employee felt better tachycardia.
I started feeling sort of congested on Saturday evening the 16th it continued to Sunday felt more like a cold. On Monday I started to feel abnormal I slept longer than normal but started coughing and Monday evening I had heavy cough then Tuesday I had chills and took my temperature, and it was 100.1 later in the day it went up to 100.7. I took COVID home test, and it was positive, I contact my doctor's office and they were closed so I scheduled a telehealth appointment on Wednesday morning after taking a second home test to verify it was also positive. Explained my symptoms to my doctor and prescribed an antiviral treatment that I started taking that evening.
5 days after vaccine (8/18/2021) I was in ER with acute appendicitis that resulted in emergency surgery to have appendix removed
Case number PHEH2014US022723, is an initial spontaneous report from a health care professional (office manager) received on 11 Nov 2014. This report refers to a 21-year-old male patient. Past medical history and concomitant medications were not reported. The patient received only Men CWY liquid conjugate component of MENVEO, (batch number: X14055) without being reconstituted with Men A lyophilized conjugate component intramuscularly on 07 Nov 2014. No adverse reaction reported following this medication error (inappropriate preparation of medication).
Within 12 hours, fever-like chills, all over body aches (joints and muscles) and extreme fatigue. Within a week numbness in both arms from shoulder to finger tips, which still persists; and arthritic symptoms in both elbows. Both elbows tender to the touch.
COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 32-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Feb2021 as dose 1, single (Lot number: EN6200), in left arm, on 19Mar2021 as dose 2, single (Lot number: ER2613), in left arm and on 15Oct2021 as dose 3 (booster), single (Lot number: FF2593) at the age of 32 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Inflammatory bowel disease" (unspecified if ongoing); "Known allergies: Sulfa drugs" (unspecified if ongoing). Concomitant medication(s) included: MESALAMINE taken for inflammatory bowel disease, start date: 23Jun2019. The following information was reported: VACCINATION FAILURE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: I tested positive and became symptomatic again. Therapeutic measures were taken as a result of vaccination failure, covid-19.  As of 26May2022, the product quality group providing investigation results included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope included the reported finished goods lot EN6200 (for dose 1), fill lot EN5332, and the formulated drug product lot EN5321. The final scope included the reported finished goods lot ER2613 (for dose 2), fill lot EP8678, and the formulated drug product lot EP8565. The final scope included the reported finished goods lot FF2593 (for dose 3), fill lot FF5584, and formulated drug product lot FA9147 respectively. A complaint sample was not returned, and photographs were not received. No related quality issues were identified during the investigation. There is no impact to product quality. No root cause or corrective/preventative actions were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications.
bleeding at the injection site; swelling at the injection site; bruising at the injection site; skin was pink where the band aid adhesive was; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE HAEMORRHAGE (bleeding at the injection site), VACCINATION SITE SWELLING (swelling at the injection site), VACCINATION SITE BRUISING (bruising at the injection site) and VACCINATION SITE ERYTHEMA (skin was pink where the band aid adhesive was) in a 65-year-old not specif patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Feb-2021, the patient experienced VACCINATION SITE HAEMORRHAGE (bleeding at the injection site), VACCINATION SITE SWELLING (swelling at the injection site), VACCINATION SITE BRUISING (bruising at the injection site) and VACCINATION SITE ERYTHEMA (skin was pink where the band aid adhesive was). At the time of the report, VACCINATION SITE HAEMORRHAGE (bleeding at the injection site), VACCINATION SITE SWELLING (swelling at the injection site), VACCINATION SITE BRUISING (bruising at the injection site) and VACCINATION SITE ERYTHEMA (skin was pink where the band aid adhesive was) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Friend, a physician, called on 10/15/13 to say patient had an adverse reaction to flu shot. On 10/9, developed SOB, wheezing, severe HA (L side of face). He had her use her albuterol inhaler and take tramadol. Symptoms started around 9 pm about 4 hrs after shot. Approx 4 hrs later, symptoms subsided.
Information has been received from a registered nurse concerning a 20 year old female, with an unspecified medical history, who was vaccinated with a dose of ProQuad. It was reported that the patient "developed swelling in her throat shortly after being vaccinated". The patient was treated with Benadryl and recovered. Unspecified medical attention was sought. No product quality complaint was involved. The patient's adverse event was considered to be other important medical event. Additional information has been requested.
Initial information received on 10 October 2014 from a healthcare provider. A 28 year old female patient was vaccinated intramuscularly on 07 October 2014 with Influenza Quadrival A-B Vaccine, batch number UI200AB, into the left deltoid. The patient had received "TIV", FLUZONE last year on an unspecified date, batch route and site not reported. The patient denied any illness at the time of vaccination, but has a history of allergies to NSAIDS and bee stings. The patient takes TYLENOL PRN and prenatal vitamins. The patient was not pregnant at the time of the report. On 08 October 2014, at 1:56 pm, the patient presented to the emergency room with abdominal pain, headache, generalized arthralgia, nausea and fever of 101.5F which the patient stated developed 1 hour post vaccination. The patient was treated with 3000 mL's of IV fluids, TYLENOL 1000 mg po, BENADRYL 25 mg po, morphine sulfate 6 mg IV, ZOFRAN 4 mg IV and 4 mg po. The patient was discharged at 6:51 pm with oral ZOFRAN and a diagnosis of viral syndrome. The patient returned to the emergency department on 08 October 2014 at 7:09 pm with the same symptoms along with "SOB", shortness of breath, swelling of the right ear to jaw, tingling of tongue and generalized sporadic raised red welts. The patient was treated with SOLU MEDROL 125 mg IV, PEPCID 20 mg IV, Doxycycline 200 mg po, ZOFRAN 4 mg IV and 1000 ml HSS IV. The patient was admitted to the hospital on 08 October 2014 at 11:20 pm with a diagnosis of acute allergic reactions. Laboratory tests were not reported. As of 10 October 2014, the patient remained in the hospital. The patient outcome is unknown. Documents held by sender: None.
10/10/07 - Received Flu and Pneumonia vaccine in L arm on 10/11/07 - 11 A - Client reported feeling "bad", "tired". (L) arm swollen, tender and red - per client. Advil taken. 10/15/07 Client feeling better - (L) arm swelling decreased.
Patient complained of feeling anxious a few minutes after receiving the vaccine, while he was just about to walk up stairs to the observation area. . Stated, "I could not see, my eyes went black, and my fingers were tingling. I almost passed out". Clinician immediately sat patient on a chair and gave him water, which he drank. Medics were called to see patient. Vital signs were WNL.  Once cleared by medics, patient was escorted to the ground level observation area. He soon reported that he was back to baseline. Medics cleared him as being medically stable. Patient reported that he no longer was light headed and had no visual disturbances. {Patient did say that he often gets anxious with needle injections.
Hematoma Cellulitis; Hematoma Cellulitis; A spontaneous report was received from a nurse professional (patient) concerning a 66-years-old female patient was who received Moderna's COVID-19 Vaccine (mRNA-1273) and had hematoma cellulitis (cellulitis) and hematoma cellulitis (haematoma).  No medical history was reported. The concomitant medications included metoprolol, colecalciferol, atorvastatin, ibuprofen.  On 28 Feb 2021, the patient received their first of the two planned doses of mRNA-1273 (Batch number: 025A21A) intramuscularly in left deltoid for the prophylaxis of COVID-19 infection.  On 28 Feb 2021, the patient developed hematoma cellulitis (medically significant).  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of the events of hematoma cellulitis (cellulitis) and hematoma cellulitis (haematoma) was unknown.   The reporter did not provide assessment for the event of hematoma cellulitis (cellulitis) and hematoma cellulitis (haematoma).; 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.
I received third dose on Thursday evening. Since then the injection site has been hot , swollen and has progressively gotten larger to the point it is now palm sized. Been using cool compress with no improvement.
Patient received her first dose of COVID-19 vaccine with the PFIZER product on 01/08/2021.   Today, 01/29/2021,  she presented for her second vaccination in the series and was erroneously given the MODERNA COVID-19  product.  No adverse events noted
Information has been received from a mother concerning her 19 year old daughter with pollen allergy who in AUG-2007 was vaccinated with a first dose of GARDASIL. Concomitant therapy included allergenic extract. She never received the second dose because when she was scheduled she had a bad cold. The patient did not seek medical attention. At the time of the report, the patient recovered from the bad cold. This one of two reports from the same source. Additional information is not expected.
Initial and follow up information has been received from a physician concerning a 35 yr old white male with allergic rhinitis and chronic sinusitis who on 13Jul04, was vaccinated SC in the left arm with a dose of pneumococcal 23v polysaccharide vaccine (lot647634/0863N). Concomitant therapy included an unspecified nasal spray. Within 24 hrs, the pt developed a fever which lasted for 3 days and swelling in his upper arms that lasted for 2 weeks. In follow up, the physician reported that on 13Jul04, at approx 23:00, the pt experienced soreness in the left arm, from the elbow to shoulder, and the left arm became swollen. The pt's arm was sore for 4 days. The physician was notified, and advised the pt to apply ice to the site and take NSAIDs as needed. Subsequently, on 17Jul04, the pt recovered. There was no product quality complaint involved. No additional information is expected.
Started with rash 4/11/2006, itchy. Mothers boyfriend has shingles.