chrisvoncsefalvay/vaers-outcomes huggingface dataset:
got the flu shot 2x & both times got sick as a dog 1 of the 2x i waz pregnant with my son it caused major problems for me; got the flu shot 2x & both times got sick as a dog 1 of the 2x i waz pregnant with my son it caused major problems for me; Initial information received on 19-Oct-2023 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case is linked to case 2023SA328390(CLUSTER).  This case involves Adult female patient who  got the flu shot (Influenza Vaccine) 2 times (2x) and both times got sick as a dog 1 of the 2x she waz pregnant with my son it caused major problems for her.  Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known.  The date of last menstrual period was not reported. The estimated due date was not reported. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient had unknown previous pregnancy/ies.   On an unknown date, the patient received a dose of suspect Influenza Vaccine by unknown manufacturer (strength, formulation, dose, route, batch number and expiry date: unknown) in unknown administration site for prophylactic vaccination. Information on batch number was requested.  On an unknown date the patient who got the flu shot 2x & both times got sick as a dog 1 of the 2x i waz pregnant with my son it caused major problems for me (illness) (exposure during pregnancy) (unknown latency).  Relevant prenatal testing after exposure included not reported.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the events.  Outcome: Unknown.  Additionally, at time of reporting, the outcome of the pregnancy is unknown.
Approximately a few months after my booster shot I contracted COVID and experienced the following symptoms: Sinus infection, and cough. I took Prednisone  for treatment. It took about 2 -3 weeks for me to recover from my symptoms.
tingling on his fingers of his left arm only; His pinky is a little bit shaky when he has his arm stretched; fever; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (tingling on his fingers of his left arm only), NERVOUSNESS (His pinky is a little bit shaky when he has his arm stretched) and PYREXIA (fever) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, the patient experienced PYREXIA (fever). On 06-Mar-2021, the patient experienced PARAESTHESIA (tingling on his fingers of his left arm only) and NERVOUSNESS (His pinky is a little bit shaky when he has his arm stretched). At the time of the report, PARAESTHESIA (tingling on his fingers of his left arm only), NERVOUSNESS (His pinky is a little bit shaky when he has his arm stretched) and PYREXIA (fever) outcome was unknown.            Concomitant medication information was not reported. Treatment information as not reported. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) is considered as not applicable.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2015, the patient was inoculated with the ZOSTAVAX vaccine at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster or shingles. In 2016, the patient was treated at a medical center for a vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Additional information has been requested.
Swollen lymph node on the neck,about  the size of a dime; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Swollen lymph node on the neck,about  the size of a dime) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced LYMPHADENOPATHY (Swollen lymph node on the neck,about  the size of a dime). At the time of the report, LYMPHADENOPATHY (Swollen lymph node on the neck,about  the size of a dime) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications information was reported. No treatment medications were provided.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
had single dose and then could not have second because of COVID; This case was reported by a consumer via interactive digital media and described the occurrence of social problem in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced social problem. On an unknown date, the outcome of the social problem was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The patient had single dose and then could not have second because of COVID. The patient asked if the patient need to start again with first.
About 2 to 3 weeks after taking the flu shot I start having pain in my left hip but at the time I didn't think it had anything to do with the flu shot. I would take 2 ALEVE and it would stop the pain but then I started to have pain and stiffness in my left shoulder, my right shoulder and knee. I told Dr. about the pain and stiffness he suggested over the counter Ibuprofen and Arthritis pain pills. When I went back to the doctor on Jan. 25 of this year with joint pain and stiffness still in my left shoulder, right shoulder, right knee and both of my hands Dr. diagnosed me with polymyalgia rheumatica. He never said the flu shot was the cause because I didn't get the vaccine at his office. But I noticed that I did not have these symptoms until after the vaccines. This condition is causing me to toss and turn all night because of the shoulder pain.
Two days after the injection the left arm turned red from the elbow to the shoulder; felt very hot and itched profusely. Went away about 5 days after the injection.  Took Benadryl tabs at nite and used Benadryl ointment in daytime to relieve itching.
Few weeks later developed shortness of breath which improved after a few weeks with steroids but still persists on exertion.  Has also new onset vertigo
Pt. had the above vaccines, awakened 24 hr later with hives over entire body, went to ER and received steroids and antihistamine.  Sx resolved within 2 days.  Mom had also given regular whole milk the same day as shots because of the formula shortage.  Possible reaction to milk.
Patient began complaining that her arm was numb, and her mouth was itchy with a metallic taste.   tongue felt "thick" but no problems breathing.  BP maintained at 120's over 80's.   Gave 50mg of benedryl and continued to observe.   Symptoms began to resolve after about 20 minutes, mouth numbness was last to resolve.
about 6PM p/vax given 2PM started crying & fever was 103 w/APAP; rt leg started swelling & turned red; seen by MD day p/vax;
t102.6 w/APAP, irritability, cont crying x 8 hrs, head jerking which lasted 6 wks continued to be irritable the next day;
Information has been received from a physician via Company representative concerning to a patient of unknown age and gender. Concurrent and historical conditions were not reported. Concomitant therapies were not provided. On 18-DEC-20145, the patient was vaccinated with an improperly stored dose of GARDASIL "10x1 sdv" (Lot No. K001631, exp. 06-NOV-2016) (dose and site not reported). The vaccine was in excursion with a sum of hours of 48. The lowest recorded temperatures was of 32 respectively. The vaccine status was reported as "in excursion". The vaccine storage criteria and type were reported as "refrigerator (R)". No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
chills; Bad Headache; This is a spontaneous report from a contactable consumer(patient). A 76-year-old (non-pregnant) female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EM9809 and Expiration Date: UNKNOWN), via unspecified route of administration in left arm on an 13Feb2021 09:45(at the age of 76-year-old) as a single dose for COVID-19 immunization. The patient medical history was not reported. Patient relevant medical history included, Sulfa Allergy, drug allergy (Amoxicillin). Other medical history reported as very good health. The patient was not diagnosed with COVID-19 prior to vaccination. Patient concomitant medications included in two weeks alendronate sodium (FOSAMAX) (MANUFACTURER UNKNOWN) on 15Feb, simvastatin (MANUFACTURER UNKNOWN), levothyroxine sodium (MANUFACTURER UNKNOWN).   Headache and chills since 16Feb Take Advil every 6 hours to mitigate reaction. Was fine day after shot, Took Fosamax on 15Feb and chills and fatigue set in that PM. On 15Feb2021 at 19:00 the patient experienced bad Headache and chills. Headaches started on 16Feb and continue. Since 16Feb2021 patient took Advil every 6 hours to mitigate reaction. On 20Feb2021, Nasal Swab COVID test was performed post vaccination included, negative result. The outcome of the event was reported as not recovered.
Patient received a live virus vaccine (MMR) on 10/6/15. She presented today for a pregnancy test which was positive. Had signed consent not pregnant and agreed to not become pregnant within 4 weeks of vaccination. Based on LMP, probable conception was the day after receiving the MMR vaccine. Report is precautionary.
2/16/11 at 7pm c/o (R) deltoid pain (10/10), swollen (3+), itching, site warm & firm to touch, erythema, below injection site & limited ROM RUE. States 'felt like fever' 2/17/11 felt exhausted, fever-did not check temp. Called PMD Rx'd & took MOTRIN 600mg & BENADRYL 25mg- felt a little better x 2-3hrs & repeated same meds at night. 2/18/11- felt better, (R) deltoid with red spots below site at 4 pm seen by PMD & Rx Amoxicillin & anti inflammatory. Took 2 doses & states on 2/19/11 possible allergic reaction to antibiotic/anti inflam. Stopped meds. 2/20/11 c/o HA & RUE s/s resolved & ROM WNL to RUE.
pt recv vax 2JUL96 & that noc pt exp itching on arms, trunk, legs & neck;3JUL96 presented to MD;had a cont rash & swelling around eyes & lips;tx w/antihistamines;
Information has been received from a physician concerning a patient of unknown age and gender. There were no current or historical conditions provided. On an unknown date the patient was vaccinated with ZOSTAVAX (lot#, expiration date, dose and route not reported). There were no concomitant medications reported. On an unknown date the patient had a rash after receiving the vaccination of ZOSTAVAX. The outcome of the event was unknown. Additional information has been requested.
Initial misuse report received from a healthcare professional on 28 May 2013. A 01-month-old patient had inadvertently received ADACEL that was supposed to be administered to another patient. No adverse event was reported. Documents held by sender: none.
Mild body aches, mild headaches, numbness and tingling down the arm injected, little light headed
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36-year-old male patient received BNT162b2 (BNT162B2), on 08Oct2021 as dose 3 (booster), single (Lot number: FC3183) at the age of 35 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. 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.
Patient tested positive for Covid-19 on 1/12/22 with onset of symptoms on  1/11/22. Symptoms included fever, muscle ache, cough and SOB. Patient was hospitalized on 1/12/22 for 4 days and developed pneumonia and ARDS.
Within an hour of second dose I started getting ringing in my ears that has not stopped. Within two days I ended up in the hospital with a blood pressure of 198/145. Have had to be on blood pressure medicine since. Recently I had a blood clot in my lungs that they say I have a clotting issue which I believe is from the vaccine also.
COVID-19 breakthrough infection. Also developed fever, coughing, achiness at injection site.; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19 breakthrough infection. Also developed fever, coughing, achiness at injection site.) in a 73-year-old female 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID-19 breakthrough infection. Also developed fever, coughing, achiness at injection site.). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency; AMOXICILLIN for Adverse event, at an unspecified dose and frequency and REMDESIVIR for Adverse event, at an unspecified dose and frequency. At the time of the report, COVID-19 (COVID-19 breakthrough infection. Also developed fever, coughing, achiness at injection site.) outcome was unknown.            Monoclonal antibodies reported as treatment medication.  Company comment: This Spontaneous case concerns a 73-year-old, female patient with no reported medical history, who experienced the unexpected, non-serious and AESI of COVID-19. The event occurred on an unknown date after booster dose of mRNA-1273 vaccine. The patient was treated with amoxicillin, Tylenol and Remdesivir. The outcome of the event is unknown. The rechallenge was not applicable. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2021-405192 (Patient Link).; Sender's Comments: This Spontaneous case concerns a 73-year-old, female patient with no reported medical history, who experienced the unexpected, non-serious and AESI of COVID-19. The event occurred on an unknown date after booster dose of mRNA-1273 vaccine. The patient was treated with amoxicillin, Tylenol and Remdesivir. The outcome of the event is unknown. The rechallenge was not applicable. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Had shingles after vaccinated/ Suspected vaccination failure; Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Family history included chickenpox (had chicken pox as kid).   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Had shingles after vaccinated/ Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt date: 22-MAR-2023 This case was reported by patients' daughter member via interactive digital media. The reporter reported that his or her mother had shingles after received Shingles vaccine. The reporter figuring the vaccine will not do good for him or her as well. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available. This case had been linked with US2023AMR058210 by same reporter for different patient.; Sender's Comments:  US-GSK-US2023AMR058210:same reporter
CAN'T CONTINUE TO FUNCTION; SEVERE HEADACHE EVERYDAY; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced can't continue to function, and severe headache everyday. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from severe headache everyday, and can't continue to function. This report was non-serious.
PT rec'd flu shot at an off site school clinic on 10-26-16, a friend of the pt stated pt had died; pt had been found deceased by her children that morning.
she still had a bruise on her left arm from that hematoma; rash; she still had a bruise on her left arm from that hematoma; 7 days after the first dose she got a big itchy rash, states it is called covid arm; 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 67 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 09Feb2021 (Lot number: EM9810) as dose 1, single for covid-19 immunisation. Relevant medical history included: "lupus" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: HAEMATOMA (non-serious) with onset 09Feb2021, outcome "recovered" (Mar2021), CONTUSION (non-serious), outcome "unknown" and all described as "she still had a bruise on her left arm from that hematoma"; RASH (non-serious), outcome "unknown", described as "rash"; RASH PRURITIC (non-serious) with onset Feb2021, outcome "unknown", described as "7 days after the first dose she got a big itchy rash, states it is called covid arm". The events "she still had a bruise on her left arm from that hematoma", "she still had a bruise on her left arm from that hematoma", "rash" and "7 days after the first dose she got a big itchy rash, states it is called covid arm" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of haematoma, contusion, rash, rash pruritic.  Additional information: She thinks part of the issue is she is a tiny person and does not have muscle in her left arm. She thinks they nicked a blood vein when they gave her the first dose since she got a huge hematoma in her left arm that hurt. She does not think it was the vaccine but from the person that administered the vaccine. It got swelled up and got huge. Treatment: She put ice on it. 7 days after the first dose she got a big itchy rash, states it is called covid arm. When she went to go get the second dose she still had a bruise on her left arm from that hematoma that gradually went away.   Follow-Up (11Oct2021): Follow-up attempts are completed. No further information is expected.
Patient was given expired MMR vaccine on October 12, 2016 at around 1:15 - 1:30 pm. Patient was fine. No treatment needed.
'pain at the injection site; stomach ache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN ('pain at the injection site) and ABDOMINAL PAIN UPPER (stomach ache) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced VACCINATION SITE PAIN ('pain at the injection site) and ABDOMINAL PAIN UPPER (stomach ache). At the time of the report, VACCINATION SITE PAIN ('pain at the injection site) and ABDOMINAL PAIN UPPER (stomach ache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the events, a causal relationship cannot be excluded.
Information has been received from a physician, concerning 4,214 Enhanced Perinatal Hepatitis B Case Management Projects (EPHBP)-managed infants born to HBsAg-positive women who completed 3 or more Hepatitis B vaccine (Recombinant) (manufacturer unknown) doses, 63.7% had reported post vaccination serologic testing (PVST) results, 13.3% had reported PVST results but infant age was unknown, and 23.0% had no reported PVST results. Of 2,683 infants with PVST results by age 24 months, 3.2% (87 infants) remained susceptible. PVST is critical for guiding medical management of infants born to HBsAg-positive women, identifying infants with HBV infection and in need of further care, and monitoring progress toward the elimination of perinatal HBV transmission. Of infants with reported PVST results and date, HBV serology status was categorized as "protected" (anti-HBs-positive, HBsAg-negative), "HBV-infected" (anti-HBs-negative, HBsAg-positive; anti-HBs-positive, HBsAg-positive; or anti-HBs unreported. HBsAg-positive), "susceptible (anti-HBs-negative, HBsAg-negative), or "indeterminate") (all other result combinations). A protective anti-HBs result was defined as >10 mlU/mL. Records of susceptible infants were reviewed for revaccination and repeat PVST. This is one of several reports from the same literature source. Additional information has been requested.