chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This retrospective pregnancy case was reported in a literature article and described the occurrence of fetal death in a female subject who received Flu Seasonal QIV Dresden. On an unknown date, less than a year after receiving Flu Seasonal QIV Dresden, the subject developed fetal death. Serious criteria included GSK medically significant and other: serious per reporter. Additional event(s) included vaccine exposure during pregnancy. The outcome of fetal death was unknown. The outcome(s) of the additional event(s) included vaccine exposure during pregnancy (unknown). The pregnancy ended in a stillbirth at greater than 22 weeks gestation with no apparent congenital anomaly present. The investigator considered that there was a reasonable possibility that the fetal death may have been caused by Flu Seasonal QIV Dresden. Additional information was provided. This retrospective pregnancy case was reported in this literature article and described the occurrence of foetal death in a female aged above 10-years who was vaccinated with unspecified seasonal inactivated influenza vaccine (manufacturer unknown) during pregnancy. The patient was a part of the study that assessed the safety of seasonal inactivated influenza vaccines (IIV) and live attenuated influenza vaccines (LAIVs) in pregnant women and their infants whose reports were submitted to Vaccine Adverse Event Reporting System (VAERS) during 2010-2016. No information on patient's medical or family history or concurrent condition or concomitant medication was provided. On an unspecified date, the patient received unspecified seasonal inactivated influenza vaccine (administration route and site unspecified; dosages unknown; batch number not provided) during pregnancy. On an unspecified date between 1 July 2010 and 6 May 2016, an unknown period after vaccine exposure during pregnancy, the patient had foetal death. This case has been considered serious as per the authors. Treatment was unknown. The authors did not comment on the relationship between foetal death and unspecified seasonal inactivated influenza vaccine. However the authors stated, "VAERS also generally cannot determine whether a vaccine caused an AE." The authors concluded that "During the study period 2010-2016, the average annual number of VAERS reports following IIV in pregnancy decreased compared with the 2009-2010 pandemic period but remained higher than prior to the pandemic. Similar to the 2009-2010 period, no new or unexpected patterns in maternal or fetal outcomes were observed during 2010-2016. Maternal influenza vaccination benefits both the mother and the infant, protecting both from influenza disease. Given that the antigenic composition of these vaccines usually changes each season, the CDC and FDA will continue to monitor the safety of influenza vaccines in pregnant women." This is 1 of the 12 valid cases reported in the same literature article.
Received HPV dose #3 at 3:15pm. Patient had loss of consciousness, pale and cold for about 1 minute.  Awoke and alert after.  Given apple juice and reported feeling improved.
muscles are very sore; can not sleep; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: En6205) via an unspecified route of administration in the right arm on 05Mar2021 at 13:00 (at the age of 58-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. 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 did not receive any other vaccines within four weeks prior to the vaccination. On 09Mar2021, the patient experienced muscles are very sore and cannot sleep. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of events. The clinical outcome for the events muscle soreness and insomnia were not recovered.   No follow-up attempts are needed. No further information is expected.
pt recvd vax & 2 days p/vax pt exp a patchy,irregular rash on lower rt leg,small red rash on chest,itching;pt was seen by MD who treated w/oral DPH & hydrocortisone;sx cont
got the flu from the shot; Initial information regarding this unsolicited valid non-serious social media case was received from a consumer and transmitted to Sanofi on 31-Oct-2020.  This case was linked to cases 2020SA307606, 2020SA307607, 2020SA307608, 2020SA307599, 2020SA307610, 2020SA307611, 2020SA307612, 2020SA307613, 2020SA307614 and 2020SA307615.  This case involved three patients of unknown demographics who got the flu (influenza) from the shot of INFLUENZA VACCINE.  Relevant medical history, past medical treatment, vaccination, concomitant medications and family history were not provided   On an unknown date, all the patients received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious flu (influenza), unknown latency following the administration of INFLUENZA VACCINE.  Relevant laboratory test was not reported.  Final diagnosis was got the flu from the shot.   It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome was unknown for the reported event.  There will be no information available on batch number for this case.
arm hurts really bad; low grade fever; knocking the mess out of me; This case was reported by a consumer via  interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 8th January 2022, the patient received the 2nd dose of Shingles vaccine. In January 2022, less than a week after receiving Shingles vaccine, the patient experienced pain in arm, fever and feeling bad. On an unknown date, the outcome of the pain in arm, fever and feeling bad were unknown.   It was unknown if the reporter considered the pain in arm, fever and feeling bad to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by the patient. The age at vaccination was not reported. The patient just got 2nd Shingles shot on Saturday and it was knocking the mess out of him/her.  The patient arm was hurting really bad and running a low grade fever.
Patient developed redness and swelling of L thigh 24-48 hours after administration of vaccine.  Pt. got his 2nd Hep A vaccine too early.  (4 months after the 1st vs 6 months after 1st).
This spontaneous report was received from a pharmacist, concerning a patient of unknown age a gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 16-JAN-2018, the patient was inadvertently vaccinated with VARIVAX lot number N022977 and expiration date of 23-AUG-2018  (dose, frequency and route were not provided) for prophylaxis, instead of ZOSTAVAX. No adverse effects. This is one of two reports received from the same reporter.; Sender's Comments: US-009507513-1801USA006250:
Parosmia - a few things are not smelling the same and have a foul odor
10/17/08 3:30 am Hives hospital ER. (10/18/08 9:22 am city hospital ER cover in hives- extreme itching-skin turning black and blue from top to bottom. BP 206/148). $ 585.81
1 rash/blister on finger for about 4 days. Itchy. Skin looks raw.  It started out looking like a hive, now it is peeling.
Immediately upon receiving vaccine , pt fell to floor onto her back and tremors of arms and legs were noted. She was unresponsive for about 7 seconds. She had hit the back of her head softly when she fell, when she became responsive she had no c/o of pain. She appeared pale. BP 92/60,P58,Resp 18, skin color improved in 10 minutes.
Since March there has been a rash on my back within 3 days of having the injection-Has persisted ever since.
This spontaneous case was initially received on 14-Mar-2016. The case report was received from a(n) Non Health Professional and concerns a(n) patient with unknown age and gender. Suspect drug(s), timing and conditions surrounding the onset of reaction(s)/event(s): The patient received an Unspecified flu vaccine on unknown dates, Batch no: not provided, Route of administration: Intramuscular, Dose: no information provided. Additional suspect drug(s): On an unspecified date, the patient received ZOSTAVAX, Batch number not provided. Reaction(s)/event(s) and outcome: On an unknown date about two weeks later, after starting / treatment with Unspecified flu vaccine and ZOSTAVAX, the patient presented to the doctor's office with what appeared to look like shingles. The shingles-like rash spread over the arm, torso, and on the lower chest; the rash looked like vesicular lesions with no particular dermatome (non serious, outcome: Unknown). Reporter's assessment: Non-serious. Case corrections (2-Mar-2016): AE 1 (LLT: skin lesions) was deleted.
Pain in left arm.irregular heart beat,numb left side of face now for a year.Blurred vision.Weakness,fainting causing injuries
1st dose Rotateq, 2nd Rotarix; This case was reported by a nurse via call center representative and described the occurrence of interchange of vaccine products in a 4-month-old female patient who received Rota (Rotarix lyophilized formulation) (batch number L4HN3, expiry date 8th July 2023) for prophylaxis.   Co-suspect products included rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis and ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) for prophylaxis.   On 8th February 2023, the patient received the 2nd dose of Rotarix lyophilized formulation and Rotarix Oral Applicator Device. On an unknown date, the patient received ROTATEQ. On 8th February 2023, unknown after receiving Rotarix lyophilized formulation and Rotarix Oral Applicator Device, the patient experienced interchange of vaccine products. On an unknown date, the outcome of the interchange of vaccine products 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 Information: GSK receipt date: 09-FEB-2023 Reporter's comment: The health department nurse reported that one of their staff members yesterday gave Rotarix vaccine to the patient who previously received a dose of Rotateq eight weeks after the Rotateq dose was give. The reporter reported that this was the patient's second dose of a rotavirus vaccine. The reporter consented to follow up. Additional supportive information: The patient received a dose of Rotarix and Rotateq, which led to interchange of vaccine products.
On 11/14, started as bumps and redness from the middle of my back to my glutes, had a presence of shingles like. Bumps went down with Benadryl cream. Then every day since then, I have had a rash that welts up appearing on my back, legs, arms, chest, and face (basically all over my body). It welts and sometimes itches. It typically comes and goes throughout the day.
I received the vaccine for shingles, ZOSTAVAX. the site of the injection is very red, swollen, itchy, painful, hot and has developed a lump. It's been about 36 hours since I've received the vaccine and my arm is continuing to get worse. The affected area is currently approximately 8 inches x 6 inches oval. I will be speaking with my doctor today.
p/vax pt devel T102 w/cellulitis & swelling on leg;
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. On 17-JUN-2013 the patient was vaccinated with GARDASIL dose 1, 0.5 ml, intramuscular. Lot number was not reported. The patient was vaccinated with dose 2, on 20-AUG-2013 and with dose 3, on 24-OCT-2013. No adverse effect was reported. Action taken regarding to the use of GARDASIL was not reported. The outcome of first dose of GARDASIL was administered on 17-JUN-2013, second dose on 20-AUG-2013 and third dose on 24-OCT-2013 and no adverse effect was unknown. Reporter causality assessment was not reported. Additional information has been requested.
Pregnant; Headache; Pain at the injectiion site; This spontaneous prospective pregnancy case was reported by a pharmacist and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant), HEADACHE (Headache) and INJECTION SITE PAIN (Pain at the injectiion site) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     Concurrent medical conditions included Pregnant. Concomitant products included LEVOTHYROXINE SODIUM (THYROXINE) for an unknown indication.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 22-Jun-2021. On 13-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant), HEADACHE (Headache) and INJECTION SITE PAIN (Pain at the injectiion site). On 13-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) had resolved. At the time of the report, HEADACHE (Headache) and INJECTION SITE PAIN (Pain at the injectiion site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided.; Sender's Comments: This case of a 28-year-old female who experienced Vaccine exposure during pregnancy.  Obstetric history, last menstrual period and estimated date of conception were unknown. Estimated due date was 22 JUN 2021. The patient experienced headache and injection site pain.  The events are temporarily associated with mRNA-1273 use, consistent with product profile and causal relationship cannot be excluded. Vaccine exposure during pregnancy is assessed as not applicable.
As per nursing notes, patient was very anxious at around 1:20 am, Thursday morning, Blood sugar 108 mg/dl, sweating profusely. O2 unable to obtain because fingers were cold. Patient started wheezing, Albuterol nebulizer treatment provided. Breathing improved. Patient claimed she was hot but she was cold and clammy.  Provided Albuterol Nebulizer treatment, 3ml. Vitals 98.2-132-22-170/88. Patient was transferred to the ER, left unit @3:38 am.
This spontaneous report was received from a other health professional refers to a patient of unknown demographics. On 30-SEP-2014 (also reported as 30-SEP-2015) the patient was vaccinated with GARDASIL lot # H021861, expiry: 09-OCT-2015 (dose, dose # and route unspecified). No concomitant medications were reported. On 30-SEP-2014, the patient received doses that were exposed to temperatures outside of the proper storage range. No adverse effect reported. The outcome of patient received doses that were exposed to temperatures outside of the proper storage range and no adverse effect reported is unknown. There was no product quality complaint (PQC) involved. This is one of several reports received from the same source. Additional information has been requested.
Patient said the 1st dose caused her to be sick in bed for 1.5 weeks with a fever over 100, early menses and red hard bumps on her face. She did not seek treatment and reported when she came in for her 2nd dose.
This spontaneous case was reported by a nurse and describes the occurrence of OVERDOSE (1 ml dose received for dose 2), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (dose 1- 28-Jan-2021 and Dose - 11-Mar-2021) and NO ADVERSE EVENT (No adverse event) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001B21A and 007M20A) for COVID-19 prophylaxis. Concurrent medical conditions included Drug allergy (Chloroquine allergy), Penicillin allergy, Hypertension, Anxiety, Eye disorder and Pain. Concomitant products included ALPRAZOLAM for Anxiety, CARVEDILOL for Hypertension, IBUPROFEN and ACETAMINOPHEN for Pain. On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 milliliter. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 milliliter. On 11-Mar-2021, the patient experienced OVERDOSE (1 ml dose received for dose 2). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (dose 1- 28-Jan-2021 and Dose - 11-Mar-2021) and NO ADVERSE EVENT (No adverse event). At the time of the report, OVERDOSE (1 ml dose received for dose 2), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (dose 1- 28-Jan-2021 and Dose - 11-Mar-2021) and NO ADVERSE EVENT (No adverse event) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for OVERDOSE (1 ml dose received for dose 2) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (dose 1- 28-Jan-2021 and Dose - 11-Mar-2021).  Patient concomitant medication included Vit C/Vit E Lutein Minerals with indication of eye health, oral, 1 capsule continuing. No treatment information reported. This case was linked to MOD-2022-630498, MOD-2022-628728 (Patient Link).
Diagnosed with a stroke; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received the second dose of bnt162b2 (BNT162B2, Solution for injection, Lot Number: EN6204), via an unspecified route of administration, administered in Arm Right on 12Apr2021 14:00 (received at the age of 66-years-old) as 2ND DOSE, SINGLE for COVID-19 immunization. The vaccine was administered at a hospital. The patient did not receive any other vaccine in four weeks prior to receiving bnt162b2. Medical history included hypertension, high cholesterol, anxiety and allergy to penicillin. The patient had no history of COVID-19 and was not tested for COVID-19 post vaccination. She was not pregnant. Concomitant medications included hydrochlorothiazide (HYDROCHLOROTHIAZIDE) taken for an unspecified indication, start and stop date were not reported; fluoxetine (FLUOXETINE) taken for an unspecified indication, start and stop date were not reported; atorvastatin (ATORVASTATIN) taken for an unspecified indication, start and stop date were not reported. The patient previously received the first dose of bnt162b2 (BNT162B2, Lot Number: EN6198), on 22Mar2021 14:30 (received at the age of 66-years-old) for COVID-19 immunization. The patient previously took macrodantin and metronidazole in which she experienced allergy. On 13Apr2021 17:00, the patient started feeling right-sided leg weakness. And by Thursday, 15Apr2021, she had arm weakness and a mild right mouth droop. She was diagnosed with a stroke on 17Apr2021. The patient stated that she thought for three days it was just a vaccine side effect and would get better, but it ended up getting worse. The adverse event stroke started on 13Apr2021 at 17:00. The adverse event resulted in Emergency room/department or urgent care, Hospitalization, Disability or permanent damage. The patient was hospitalized for 6 days. It was unknown if the patient received corrective treatment. Outcome of the event was recovered with sequel on an unspecified date.
Arm very swollen and hot to touch. Each day swelling gets a tad bit bigger. Complaints of pain in that area.
broke out in hives; This case was reported by a consumer via interactive digital media and described the occurrence of hives in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced hives. On an unknown date, the outcome of the hives was unknown.   It was unknown if the reporter considered the hives to be related to Shingles vaccine.  Additional details were provided as follows: The patient self reported the case. The age at vaccination was not reported. The patient received shingle shot and broke out in hives. The patient did not know if he/she could take the other one or not. The follow up would not be possible as no contact details were available.
5 yo shots 3/4/10 - saw on 3/5/10 describing large red knot documented by MD.
Pt reports 101 fever, body ache, arm/shoulder/neck pain/immobility to raise arm/also b/L knee pain (s/p knee replacement). Also reported to PCP.
This spontaneous case was reported by a consumer and describes the occurrence of  in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ADVERSE EVENT (Adverse Event). At the time of the report, outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Upon in internal review on 21 May 2021, the age was corrected to unknown age.  No concomitant medication was provided.  No treatment details were provided.
Trouble walking with right leg, red, swollen toes which come and go, I could not drive for several months, My foot still swells and I am in constant pain. Doctor says I have chilblains.
9OCT98 pt recv vax & c/o pain, large hard reddened area on arm below site (2" below);took flexeril & naprosyn for severe pain that PM;11OCT98 devel rash (small, red blister-looking, itches on back, abd & groin area;
Pt is on hospice services for 5 months for CVD/CVA.  On 2/8/21 pts dtr called to report new onset seizure (no hx of seizures).  Per dtr report only change in pts condition is that he rcvd the COVID vaccine on Saturday  2/6/21.  Dtr called 911 due to severity of seizure.
He was diagnosis on March 6, 2023 with anemia and they added vitamin D3 and iron to his medication. March 19, 2023, he was taking by ambulance to the hospital. They diagnosis him with hallucination and anxiety. They also said he should avoid smoke because it may be a trigger to the seizure.
No side effects; HAV adult administered on 07-AUG-2000 and 08-JUN-2002; This spontaneous report was received from a lawyer concerning a 53-year-old male patient.  His concurrent conditions, medical history, drug reactions, allergies and concomitant medications were not reported.  On 07-AUG-2000, the patient was vaccinated with Hepatitis A Vaccine, Inactivated (manufacturer unknown) as prophylaxis (dose, dosage schedule, lot number, frequency, route and site of administration were not reported). On 08-JUN-2002, the patient was revaccinated with Hepatitis A Vaccine, Inactivated (manufacturer unknown) as prophylaxis (dose, dosage schedule, lot number, frequency, route and site of administration were not reported). No side effects were reported.   On 28-SEP-2009, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown). On 14-FEB-2014, the patient was revaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (captured in MARRS # 2107USA007285). Also that date, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) and subsequently experienced shingles, vaccination failure along with other events (captured in MARRS # 1809USA008171).; Sender's Comments:  US-009507513-1809USA008171: US-009507513-2107USA007286:
Rash all over body.  Small red dotes/whelps in some areas.  Epi injection per ER.  Prescribed Benadryl, now Atarax.
Severe swelling on right knee and left elbow (hot,red, 6 cm swelling soft tissues).  had to visit many doctors (urgent care, primary, orthopedics surgent, rheumatologist).  did steriod injection to reduce swelling.  left elbow still not fully recovered yet as of 5-7-2022.