chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No additional AEs; the fluid dripped down his arm, onto his leg and onto the chair; This spontaneous report was received from a male patient of unknown age reporting on himself.  No information was provided regarding the patient's medical history, concurrent conditions, past drug history or concomitant medications.    On 23-SEP-2021, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) for prophylaxis (dose, route and site of administration, lot number and expiration date were not reported).     The patient stated the fluid dripped down his arm (exposure via skin contact), onto his leg and onto the chair.  No adverse events were reported.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 25-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
low grade temp (99.4); nausea; diarrhea; muscle aches; fatigue; chills; joint pain in both of my hands; sore at the injection side; muscle spasms continued and spread to the left side of my face, resulting in twitching in my left cheek, left eyelid, and left side of my nose; muscle spasms continued and spread to the left side of my face, resulting in twitching in my left cheek, left eyelid, and left side of my nose; sleeplessness; Eight hours after I received my shot in my left arm, I began experiencing muscle twitching/spasm in that arm/They ran along my left forearm and into my fingers, particularly my left pointer finger; Eight hours after I received my shot in my left arm, I began experiencing muscle twitching/spasm in that arm/They ran along my left forearm and into my fingers, particularly my left pointer finger; This is a spontaneous report from a contactable consumer. A 37-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 11Apr2021 14:00 (Batch/Lot Number: er8729) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included crohn's disease, drug hypersensitivity. The patient experienced that eight hours after I received my shot in my left arm, I began experiencing muscle twitching/spasm in that arm. They ran along my left forearm and into my fingers, particularly my left pointer finger, resulting in that finger moving on its own. By 9 am the next morning, the twitching was still present in my left arm, and I had also developed a low-grade temp (99.4), nausea, diarrhea, muscle aches, fatigue, chills, joint pain in both of my hands, and was sore at the injection side. These symptoms persisted for 48 hours. Additionally, the muscle spasms continued and spread to the left side of my face, resulting in twitching in my left cheek, left eyelid, and left side of my nose. I also experienced sleeplessness. By day 4, the symptoms were all lessening, with most gone entirely except the muscle twitching in my left arm and left side of my face. The outcome of the events was recovering.   No follow-up attempts are possible. No further information is expected.
Initial report was received from a healthcare professional on 05 December 2011. A 36-year-old male patient had received an injection of FLUZONE INTRADERMAL (lot number not reported) in left deltoid on 22 November 2011. On 24 November 2011, the patient developed pain from shoulder to elbow and numbness and tingling in hand. According to the patient, the nurse grabbed his muscle and injected the vaccine. The patient received corrective treatment with ibuprofen and "slight" improved. No further information was available at the time of the report. The patient outcome was reported as not recovered/not resolved. Documents held by sender: none.
Chills; fever; body aches; dull headache; vomiting; This is a spontaneous report from a contactable consumer (patient). This 44-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EL926lt) via an unspecified route of administration in the left arm on 07Feb2021 at 12:00 (at the age of 44-years-old) as a single dose for COVID-19 immunization. Medical history included ulcerative colitis from an unknown date and unknown if ongoing. The patient did not have allergies to medications, foods or other products and was not diagnosed with COVID-19 prior to vaccination. The patient had no concomitant medications. The patient previously received infliximab (REMICADE) infusions from an unknown date for ulcerative colitis; and received the first dose of BNT162B2 (lot number El3247) in the left arm on 17Jan2021 at 12:00 (at the age of 44-years-old) for COVID-19 immunization. The patient did not receive any other vaccines within the 4 weeks prior to the COVID vaccine. On 08Feb2021 at 00:15 the patient experienced chills, fever, body aches, dull headache, and vomiting. The events were reported as non-serious and did not require hospitalization. No treatment was provided for the events. The events of chills, fever, body aches, dull headache, and vomiting were recovering. It was also reported the patient had not been tested for COVID-19 since vaccination.
An 1 h and 20 mins after vaccine was given, driving home and felt some difficulty swallowing.  Was able to drink water no difficulty  but unable to do swallow without the aid of water.  No SOB,  some tachycardia.  Went to closest ED.
Dizziness and lightheadedness; Difficulty swallowing for 15 minutes; This is a spontaneous report from a non-contactable pharmacist. A 26-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0151) via intramuscular route of administration on 04Jun2021(at the age of 26-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, it was unknown that the patient was diagnosed with COVID-19. Concomitant medications were not reported. On an unknown date in 2021, the patient experienced dizziness, lightheadedness and difficulty swallowing for 15 minutes. The events did not result in doctor or other healthcare professional office/clinic visit. Since the vaccination, it was unknown that the patient had been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events dizziness, lightheadedness and difficulty swallowing was resolved on an unknown date in 2021, after a duration of 15 minutes.    No follow-up attempts are possible. No further information is expected.
Flu; This case was reported by a pharmacist via call center representative and described the occurrence of influenza in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   In August 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 9 months after receiving Shingrix, the patient experienced influenza. On an unknown date, the outcome of the influenza was unknown.   It was unknown if the reporter considered the influenza to be related to Shingrix.  Additional details were provided as follows: The age at the vaccination was not reported. The reporter did not had any patient or vaccine details as the customer mentioned that was at home and does not have any data at the moment. The age group was selected as an adult as per indicated age of Shingrix. Pharmacist called asking for medical information for a patient that receive the first dose of Shingrix and due to the social distancing and the situation with the COVID-19 would not be able to come to get the second dose. Also mentioned that the patient did not came for the second dose due to a flu. Consented to follow up. This case is linked to the case US2020059042, reported by the same reporter.
My heart rate and blood pressure went up for two days.; My heart rate and blood pressure went up for two days./her blood pressure was 160/82; felt lightheaded; This is a spontaneous report from a contactable consumer or other non-health care professional and other health care professional. A 81-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: Unknown), via an unspecified route of administration on 19Mar2021 (at the age of 81-year-old) as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took olmesartan for blood pressure, indapamide, atorvastatin for blood cholesterol, potassium chloride for blood pressure. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient reported that she was trying to decide if she should keep her appointment for the second dose of the Pfizer-BioNTech COVID-19 vaccine. The patient received the first dose on 19Mar2021, was scheduled to receive the second dose on 13Apr2021, and reported to have had some possible side effects. She felt okay within 15 minutes after the first dose. When patient was on her way home (25-28 minutes after) the patient felt lightheaded. Upon checking, her blood pressure was 160/82 and heart rate was 72 bpm (beats per minute) and this continued to go down the rest of the day. The patient asked if this are normal side effects. The patient's husband has allergies and asthma had both Pfizer vaccines no side effects. The patient took the first vaccine and 25 minutes after heart rate and blood pressure went up for almost two days. The adverse events were not resulted in a visit to emergency room and physician office. The patient underwent lab tests and procedures which included blood pressure measurement: 160/82 on 19Mar2021 (Elevated), blood pressure: 121/74 on 19Mar2021 (came back down), blood pressure: 115/69 on 19Mar2021 (back down), heart rate: 72 bpm (beat per minute) on 19Mar2021, heart rate: 75 bpm (beat per minute) on 19Mar2021, heart rate: 96 bpm (beat per minute) on 19Mar2021 (Elevated). The outcome of "felt lightheaded" was reported as resolved on 19Mar2021; blood pressure increased, and heart rate increased was resolved on 20Mar2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
started spotting and started having her period again; started spotting and started having her period again; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 48 year-old female patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INTERMENSTRUAL BLEEDING (non-serious), MENSTRUAL DISORDER (non-serious), outcome "unknown" and all described as "started spotting and started having her period again".  Additional Information: States that she did not know if what she experienced was a side effect of the vaccine but she was told to call and report any possible side effects. States that both of her girls are 15 years old, and when they got their Pfizer Covid 19 vaccines they both got swelling and pain at the injection site, but one of them has started to feel a stabbing pain. Clarified that one of her girls had an episode yesterday where she felt a stabbing pain around her heart area. Verified that both girls are 15. Declined to provide mailing address or email address.   This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
This is a spontaneous report received from a Pfizer sponsored program, via a contactable consumer (reporting for her sons). This consumer reported similar events for 2 patients. This is for the 2nd of two reports. A male patient of an unspecified age and ethnicity received first dose of TRUMENBA, via an unspecified route of administration on Jul2017 at a single dose for immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced fatigue and headache, but it only lasted two days. The reported also stated that the pediatrician office does not seem to know what was going on with the dose schedule. The outcome of the event was recovered. The patient will be getting the second shot at the end of Nov2017, which would be 4 months after the first dose. Sender's Comments: Linked Report(s): US-PFIZER INC-2017479958 Same drug/AE for different patients.
Hard time walking; O2 levels decreased to 88%; He's had covid symptoms before but these are worse this time; He's having a harder time breathing; This spontaneous case was reported by a consumer and describes the occurrence of GAIT DISTURBANCE (Hard time walking), OXYGEN SATURATION DECREASED (O2 levels decreased to 88%), COVID-19 (He's had covid symptoms before but these are worse this time) and DYSPNOEA (He's having a harder time breathing) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L2OA) for COVID-19 vaccination.     Concurrent medical conditions included COVID-19.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced GAIT DISTURBANCE (Hard time walking), OXYGEN SATURATION DECREASED (O2 levels decreased to 88%), COVID-19 (He's had covid symptoms before but these are worse this time) and DYSPNOEA (He's having a harder time breathing). The patient was treated with OXYGEN for Oxygen saturation decreased, at a dose of level 1 to level 3. At the time of the report, GAIT DISTURBANCE (Hard time walking), COVID-19 (He's had covid symptoms before but these are worse this time) and DYSPNOEA (He's having a harder time breathing) had not resolved and OXYGEN SATURATION DECREASED (O2 levels decreased to 88%) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Oxygen saturation: 88 % (Low) decreased to 88%.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not reported. Oxygen was increased from usual level 1 to level 3.  It was reported that the patient was using walker at the time of report because he had a harder time walking. The patient had to use walker 2 days after the injection.  Patient was due for 2nd shot in the next 2 weeks to the day of report. The patient also had a follow-up visit 3 days prior to the report with his HCP and did not know what to do. The patient was told to take Aleve but denied taking it.
pt states p/vax 6OCT97 that evening arm became red, sl swollen & warm to touch, just under inj site on lt arm;pt was seen @ hosp 9OCt97; dx local rxn to Td vax;tx w/cold compresses to lt upper arm, prescription for keflex;
Redness and mild swelling in Left arm .Slight rash ,Onset 6-25-06 that lasted one day. No wheezing or cough.
Information has been received from a health professional concerning a 15 year old white female who on 27-NOV-2007 was vaccinated with the second dose of Gardasil (lot# 657736/0389U).  Subsequently the patient fainted after the vaccination.  She was fine with the first dose.  Unknown medical attention was sought.  The patient's outcome is unknown. No product quality complaint was involved.  This is one of the multiple reports from the same source.  Additional information has been requested.
Information has been received from a consumer concerning his 65 year old wife who on an unspecified date was vaccinated with ZOSTAVAX (Merck) (lot# not reported). Subsequently the patient experienced intense redness, itching and blisters. At the time of the report, the outcome of the events was unknown. No further information is available.
February 21, 2021 around 4 pm, a woman on the passenger  seat of a car, driven by her husband began feeling ? dizzy?. I was approached by our CIO to see her immediately. Another Nurse  came to the rescue and we both assessed the patient. She was awake, alert, oriented but anxious and stating she's dizzy. The back of the seat was lowered down for her comfort and blood pressure was taken. It was 172 /100 mmhg. PR = 72 , Temp = 97.5. RR = 18. Two other RNs came to help. The patient was conversant, her husband was upbeat and being funny. Pt started to play with her dog from the backseat reaching for it. The patient was talking but I decided to tell patient to relax since vital signs will be taken again. BP repeated after 6 minutes and its now 155/100, PR= 75, RR=19, TEMP= 97.3, 02 Sat @89 % . Pt?s hands were cold now. O2 Sat was also hard to get a good reading on all of her fingers. Called Dr. Cat Forest and she came to the scene comforting patient while vitsal signs were repeated again after 5 minutes  after they were taken Now getting BP=  55/110 mmhg, PR: 80, Temp 97.2 and O2 Sat still at 89% Pt was adviced to go the ER after the Patient?s O2 Sat stayed at 89% and also after finding out that patient haven?t had any physical for two years and that patient doesnt check her blood pressure. Pt and her husband were counselled on the importance of getting regular check up especially at her age of 69 years old. Husband drove patient to the ER per order. Called patient on Monday, 2/23 and Tuesday, 2/24 with no answer. emailed patient and patient answered back and she said that she went to the ER with her husband that day and was discharged and feeling better and wanting to thank the staff for the way she was taken cared of and hoping they will be there for her second dose when she comes back.
HEADACHE,  LIGHTHEADED, BODYACHES, LITTLE NUMBNESS IN THE RIGHT CHEEK  B/P 152/93  PULSE 96 @ 12:55PM PATIENT STATED SHE IS NOT GETTING WORSE @1:26PM PATIENT REFUSED EMERGENCY SERVICES AND/ OR CALLING MD
Delayed injection site swelling, red banding rash across injection site about 3 inches wide, hard center, hot, itchy. Occurred 8 days after first dose of vaccination.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 65-year-old female patient who received SHINGRIX (batch number C523T, expiry date 4th July 2020). Concurrent medical conditions included blood pressure abnormal, blood cholesterol abnormal and diabetes. Concomitant products included Water Pill. On 12th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 12th April 2018, immediately after receiving SHINGRIX, the patient experienced injection site pain. In April 2018, the patient experienced fever, erythematous rash and injection site erythema. In April 2018, the outcome of the injection site pain and fever were recovered/resolved and the outcome of the erythematous rash and injection site erythema were not recovered/not resolved. The reporter considered the injection site pain, fever, erythematous rash and injection site erythema to be almost certainly related to SHINGRIX. Additional details were provided as follows: The patient was taking concomitant medication for blood pressure, cholesterol and diabetes. The pharmacist who administered the injection called and reported the patient experienced pain and soreness immediately after the injection in the right upper arm. In April 2018, less than a month after vaccination, the patient experienced a red rash that travelled up the arm to the shoulder and a mild fever after the injection. The pharmacist stated that, at the time of reporting, all symptoms had resolved except there was still slight redness at the injection site. No additional information was available at the time of the call. The reporter gave permission to contact her and would like to receive follow-up in related to this adverse event. This case was linked to case US2018071879, as reported by same reporter.
Lethargic; Fatigue; Headache; This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (Lethargic), FATIGUE (Fatigue) and HEADACHE (Headache) 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 09-Feb-2021 at 2:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, the patient experienced LETHARGY (Lethargic), FATIGUE (Fatigue) and HEADACHE (Headache). At the time of the report, LETHARGY (Lethargic) and HEADACHE (Headache) had not resolved and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
FEVER; BARFED; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's past medical history included: covid-19. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced fever, and barfed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever and barfed was not reported. This report was non-serious.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-healthcare professional) for a Pfizer sponsored program (005570). The reporter is the patient. A patient (no qualifiers provided) received bnt162b2 (BNT162B2) administration date 04Oct2021 (Batch/Lot number: Unknown) as dose 3 (booster), single for covid-19 immunisation. The patient relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), administration date: 20Jan2021 for COVID-19 immunisation, Bnt162b2 (DOSE 2, SINGLE), administration date: 10Feb2021 for COVID-19 immunisation. The following information was reported: IMMUNISATION (non-serious) with onset 04Oct2021, outcome "unknown", described as "booster shot on 04Oct2021", PROTEIN TOTAL ABNORMAL (non-serious) with onset 29Nov2021, outcome "unknown", described as "I had a spike proteins test done on 29Nov2021. The results were I had a number of 5034.4". Relevant laboratory tests and procedures are available in the appropriate section.  The lot number for bnt162b2 was not provided and will be requested during follow up.
This is a spontaneous report obtained from a contactable nurse through a Pfizer sales representative. A 65 year old patient of an unspecified gender and ethnicity received, on 22Jul2015, PREVNAR 13 single dose. Relevant medical history and concomitant medications were unknown. On an unspecified date, in Jul2015, the patient experienced fever and cellulitis. The patient was treated with KEFLEX. Clinical outcome of the events was unknown at time of this report. The nurse believed that the patient got cellulitis from PREVNAR 13.