chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse symptoms reported; First dose of GARDASIL 9 was administered in November 2019 and second dose of GARDASIL 9 was given in 03-JUN-2020; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's concurrent conditions, historical conditions and concomitant therapies were not reported.  On an unknown day in November 2019, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (route of administration, lot number and expiration date were not reported) for prophylaxis. On 03-JUN-2020, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (route of administration was not reported, lot number R029515 and expiration date: 08-JUL-2021) for prophylaxis (inappropriate schedule of product administration). No adverse symptoms reported. No additional information provided. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: R029515; expirationdate: 08-JUL-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent
Administered expired vaccine; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 15-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 15-Mar-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine). On 15-Mar-2021, EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine) had resolved. Not Provided      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.; Sender's Comments: This report refers to a case of Expired Product Administered for mRNA-1273 (Lot #: 014M20A)  with no associated AEs
From initial information received on 21Jan05 from another manf (HQWYE394611NOV04) regarding an adverse event occurring, it was initially reported by a physician that a four month old male pt received a dose of Acthib and a dose of Ipol on 20Dec01. The lot number, route and sites of administration were not reported. 24 hrs later, on 21Dec01, the pt developed hives and a low grade fever. Reportedly, he recovered from these events.
Fever; severe soreness at the injection site; The muscle is sore; she feels like her arm is fatigued; she feels like her arm is fatigued; worst pain; This is a spontaneous report from a contactable consumer (patient herself).   A 52-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot number: ER8730, Expiry date, NDC was not reported), via an unspecified route of administration on 26Mar2021 (Age at vaccination 51-years-old) as dose 1, single for covid-19 immunization. Medical history included, she's a cancer survivor from an unknown date and unknown if ongoing, got sunburned from 2019 to an unknown date. There were no concomitant medications. The patient arm isn't weak, but the muscle is sore and fatigued like she went to the gym. The patient had the worst pain, fever and severe soreness at the injection site on an unspecified date 2021 after the first dose. When the patient lifts her arm now it's like her deltoid is pulling from the back all the way to the armpit ever since the injection. The pain started within 12 hours of the vaccine and the patient got up in the middle of the night and didn't know what the hell she did to herself. The patient took some Tylenol and was fine by Sunday, but Saturday was the worst. The patient recovered completely from the symptoms after the first dose. The patient didn't have any problems with the first vaccine, her friend who was a nurse said she is still feeling sore. The patient can be sitting down and she feels like her arm is fatigued and a pulling under her arm like the back of her breast. The patient went to the doctor for this. Therapeutic measures were taken for the events. The patient received Tylenol as treatment for the events. The clinical outcome of the events was recovered on an unspecified date 2021.  Follow-up attempts are completed. No further information is expected.
Very heavy and unusually early menstrual cycle (by 5 days); Very heavy and unusually early menstrual cycle (by 5 days); Also shorter in duration ( only 3 days instead of 5); It also is much thinner blood than usual; This is a spontaneous report from a non-contactable consumer, the patient. A 39-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0161) via an unspecified route of administration on 19Apr2021 (at the age of 39-years-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. On 01May2021, the patient experienced very heavy and unusually early menstrual cycle (by 5 days) and also shorter in duration (only 3 days instead of 5). It also was much thinner blood than usual. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events very heavy and unusually early menstrual cycle (by 5 days), also shorter in duration (only 3 days instead of 5) and it also was much thinner blood than usual was recovered on an unknown date in May2021.  No follow-up attempts are possible. No further information is expected.
Case number PHEH2013US008868 is an initial combined report received from a consumer (nurse) on 18 Apr 2013 with a follow up information received from quality assurance department (QA reference number: 224311) on 22 Apr 2013. This report refers to a 27-years-old female patient. It was reported that during administration of a dose of MENVEO (batch number: A12025, expiry date: Dec 2014) to a patient, some of the vaccine splashed back on to her face because the syringe had a slip tip and needle popped off on 18 Apr 2013. The vaccine administrator was pregnant. No adverse reactions were reported. The quality assurance department registered a complaint with reference number 224311. No further information was provided.
Flu vaccine administered at approx 2 pm, at approx. 5:45pm, patient thought she had something lodged in throat.  looked in mouth and observed swelling in throat and had "nerve pain in mouth and throat area" also experienced chest pain across front and back, had coughing and runny nose. Took Baclofen and aspirin and laid down.  At approx. 10pm, her symptoms subsided.
Received two COVID vaccines on 1/14 and 2/4. On 4/30 seen for cough, HA, runny nose, fever. Rapid test done with a POSITIVE result for COVID 5/3: Today, patient states that he feels better.
Beginning with headache, progressing to severe headache with dizziness and c/o of bilateral flank pain.  After 2 days patient returned to work on night shift and symptoms returned and worsened over subsequent 2 nights of work.  On 6th day after administration headache/dizziness was so severe patient experienced vomiting and loss of visual field. Pt was taken to ER by spouse.  Treated for dehydration, nausea and pain.  Returned home after treatment. Received prescriptions for pain, dizziness and nausea.  Instructed by ER to remain off work x 3 days.
After I received the first Gardasil vaccine, I began having body pains. My doctor did every test possible but could not find what was causing it. After the second vaccine, the pain got much worse. The night I received my third Gardasil injection, I got a fever of 103.4 and I passed out. I wasn't able to move my body for three days. The sharp pains throughout my entire body became unbearable. There are days when I curl up in a ball and can't move. I started breaking out like I have never seen before. Every inch of my face and chest is covered with acne. I get dizzy and throw up at least once a day. I have severe headaches that lead to confusion. Flashing lights cause me to black out. I sometimes get an increased heart beat that makes me feel like I'm going to have a heart attack. I often get severe chest pains and find it hard to breathe. Since the first vaccine I have been suffering from insomnia. The only way I sleep is if I take a sleep aid. All these symptoms have only gotten worse. I feel like my body is shutting down and I'm dying.
High Fever, chills, unable to stop shivering for hours. Tylenol did not help. Every joint in my body ached. It felt like I was beaten by a baseball bat.Barely able to walk . It was 48 hours before I was able to get out of bed and do anything I had a similar but lesser reaction with the first Pfizer vaccine. After the first vaccine I recovered in 36 hours. I have never had reactions to the flu vaccine. These were NOT the mild side effects that I was told might occur.
vaccines do not help prevent; vaccines do not help prevent; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID:. The reporter is the patient.  A 30-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) 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), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "vaccines do not help prevent". Clinical course: Patient was vaccinated 6-12months ago and caught Covid one month ago (as of 14Jul2022) so the vaccines do not help prevent at all. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Redness, swelling at injection site of MENACTRA. DEPO MEDROL 80mg IM given Rt vent. gluteal also that day.
Following administration of Td, pt exp body pain, h/a, backache, mild temp elevation, several days p/inject, pt recovered;
Information has been received from a registered nurse concerning a 27 year old Hispanic female clinic employee with no allergies or medical history who on 15 Aug 2006 at 12:30 PM  was vaccinated SC in the right arm with a 0.5 mL dose of MMR II. Concomitant therapy included a tuberculin purified protein derivative test. On 17 Aug 2006, the employee developed itchy red papule spots on her trunk. Unspecified medical attention was sought. At the time of the report, the patient had not recovered. A product quality complaint was not involved. Additional information has been received from a registered nurse who reported that on 17  Aug 2006, the patient reported red, itchy bumps on her abdomen, upper thigh, waistline, and buttocks. No diagnostic laboratory tests were performed. The patient recovered on an unspecified date. No further information is expected.
child developed a 3 inch x 3 inch area of redness around injection site.  Motrin given last pm by parent, tylenol given in office today.
11/12 Developed chest pain while playing basketball, seen at outside ER. By mom's report CXR, ECG, blood nl. Was better slight URI sx 11/13 - 11/16 was at school sitting, laughing and talking to friends, collapsed and unable to be resuscitated. Pronounced dead at outside ER.
Did not squeeze the muscle before administering the vaccine; pain in the arm /a lot of pain in upper quad of my arm; Cannot lift arm over head; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in the arm /a lot of pain in upper quad of my arm), HYPOKINESIA (Cannot lift arm over head) and WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (Did not squeeze the muscle before administering the vaccine) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003421A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported.).    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, the patient experienced WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (Did not squeeze the muscle before administering the vaccine). In March 2021, the patient experienced PAIN IN EXTREMITY (pain in the arm /a lot of pain in upper quad of my arm) and HYPOKINESIA (Cannot lift arm over head). On 15-Mar-2021, WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (Did not squeeze the muscle before administering the vaccine) outcome was unknown. At the time of the report, PAIN IN EXTREMITY (pain in the arm /a lot of pain in upper quad of my arm) and HYPOKINESIA (Cannot lift arm over head) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Skin pain around hips and upper pubic region. Also skin pain - upper stomach area, Lasting tinitis.
rash was a little big but after the second shot it got quite worse. As far as worse she states itching and swollen; rash is on her face and down onto her neck and her left shoulder, she received the shot on her  left side and it itches; rash was a little big but after the second shot it got quite worse. As far as worse she states itching and swollen; she received the shot on her  left side and it itches; This is a spontaneous report from a contactable consumer (patient). An 85-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EN6200), via an unspecified route of administration on 23Feb2021 14:15 (at the age of 85-years-old) at 2nd dose, single dose in the left arm for COVID-19 immunization. Medical history included ongoing rash. The patient has no concomitant medications. Historical vaccine included first dose of BNT162B2 received on 02Feb2021 for COVID-19 immunization and experienced rash (in the first shot but it was nothing worth). The patient reported that before receiving the second dose on 23Feb2021, she developed a rash which was a little big. She thinks that the rash may have been there a little before she received the second shot. Then after receiving the second dose of the vaccine, she reported that the rash got quite worse. Further stated that the rash was itching and swollen. The patient saw her doctor a week ago, on 03Mar2021, and the doctor felt that this rash was insignificant and did not prescribe any course of treatment. The patient stated that the rash was on her face, down to her neck and left shoulder. The patient received her Pfizer COVID vaccine shot on the left side, and it itches. The patient stated that it has been over 2 weeks and she still have the rash. But the patient stated that the rash was improving, it was not as red and was less itchy. The patient asked when it will go away. The patient had a blood work done on an unspecified date, before going to see the doctor, and reported that the results were normal. For the patient, the rash was not life threatening, however it was uncomfortable. The events rash aggravated, itchy rash, and swelling resulted in physician's office visit. The patient did not receive any treatment for the events rash aggravated, itchy rash, and swelling. Outcome of the event rash aggravated and itchy rash was recovering, and for other events was unknown.   Follow-up attempts are completed. No further information is expected.
6 days after injection, I noticed a 5x5 cm sized lump under my left  arm.
Patient received vaccine 21 days after first dose instead of 28 days, Pt had not signs or symptoms
Pt received a flu shot on 9/23/10 and called in on 10/29/10 to report that shot was given high in arm and had pain in arm. His doctor asked for another shot to be given. This was done. Spoke to pt on 1/4/11 and conts to have pain in arm - possible surgery - has been on steroids x 2.
Covid-19; Fever 102 F; Very Fatigue; Under weather; Cough; A spontaneous report was received from a consumer concerning a 66-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events cough, very fatigue, under weather, fever 102 f, covid-19.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 1 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 013L20A) intramuscularly for prophylaxis of COVID-19 infection.  On 4 Feb 2021, the patient experienced the event cough. On 6 Feb 2021, the patient experienced the events  very fatigue, under weather. On 7 Feb 2021, the patient experienced the events fever 102 f. On 9 Feb 2021, the patient experienced the event covid-19.Consumer visited HCP. HCP recommended over the counter medications to treat symptoms.  Treatment details included acetaminophen, azithromycin, mucinex, Ibuprofen.  Action taken with mRNA-1273 in response to the events was not reported.  On 5 Feb 2021 the outcome of event, cough was resolved. The outcome of events, very fatigue, under weather, fever 102 f, covid-19 was unknown.
Systemic: Dizziness / Lightheadness-Mild, Systemic: Shakiness-Mild
ITP; Petechia all over the body; hemolytic anemia; shock; Initial information was received on 12-Aug-2021 regarding an unsolicited valid serious case from a consumer/non-healthcare professional (hcp).  The case is linked to 2021SA274876.  This case involves an unknown age male patient who experienced serious ITP (immune thrombocytopenia), petechia all over the body (petechiae), hemolytic anemia and dying in shock (shock) after receiving DIPHTHERIA, TETANUS AND NOS PERTUSSIS VACCINE.  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  On an unknown date, (around the time of birth) the patient received dose of suspect DIPHTHERIA, TETANUS AND NOS PERTUSSIS VACCINE produced by unknown manufacturer (lot number and expiry date were not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a serious ITP (immune thrombocytopenia), petechia all over the body (petechiae), hemolytic anemia and dying in shock (shock) (unknown latency) following the administration of DIPHTHERIA and TETANUS AND NOS PERTUSSIS VACCINE. These events were assessed as medically significant.  It was reported that he was a test kid for Sandoglobulin.  Details of laboratory data was not reported.  It was not reported if the patient received any corrective treatment for the events.  At time of reporting, patient is 38 years old, the outcome was Unknown for all the events.; Sender's Comments: This case involves an unknown age male patient who had immune thrombocytopenia, petechiae, hemolytic anemia and shock after vaccination with DIPHTHERIA, TETANUS AND NOS PERTUSSIS VACCINE (unknown manufacturer). The time to onset is unknown. Additional information regarding medical history, condition at the time of vaccination and lab data excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, role of the vaccine cannot be assessed.
None stated.  Follow-up - None - No adverse Rxw - adult vaccine given to child.
sinus condition; ear infection; This spontaneous case was reported by a consumer and describes the occurrence of SINUS DISORDER (sinus condition) and EAR INFECTION (ear infection) in a male patient of an unknown age 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced SINUS DISORDER (sinus condition) and EAR INFECTION (ear infection). At the time of the report, SINUS DISORDER (sinus condition) and EAR INFECTION (ear infection) outcome was unknown.            No concomitant medications were provided by the reporter.  The patient reported developing an ear infection and sinus condition on 24FEB2021 before he received the 2nd dose on 10MAR2021.   Treatment for the events included ceftriaxone, dexamethasone shots, and sulfamethoxazole-trimethoprim.   Most recent FOLLOW-UP information incorporated above includes: On 06-May-2021: Follow up received on 06-MAY-2021 and contains no new information.
accidentally get Shringrix in her eye; accidentally get Shringrix in her eye; This case was reported by a nurse via call center representative and described the occurrence of accidental occupational exposure to product in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced accidental occupational exposure to product and exposure via eye contact. On an unknown date, the outcome of the accidental occupational exposure to product and exposure via eye contact were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The nurse reported that their colleague accidentally exposed to Shringrix in her eye, which led to accidental occupational exposure to product and exposure via eye contact. The patient used the eye wash station. The reporter enquired if there was any other recommendations. The reporter consented to follow up.
With his second COVID vaccine he felt warm; headache; he just felt very tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1), for covid-19 immunisation, reaction(s): "his arm was sore". The following information was reported: FEELING HOT (non-serious), outcome "unknown", described as "With his second COVID vaccine he felt warm"; HEADACHE (non-serious), outcome "unknown", described as "headache"; FATIGUE (non-serious), outcome "unknown", described as "he just felt very tired".  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-2021302405 same reporter /drug, , different patient and event
After 2nd Anthrax shot, pt developed hives and facial swelling for 2 days.
Information has been received from a physician concerning a 14 year old female patient who on an unknown date was vaccinated with the second dose of GARDASIL.  It was reported that after getting the second dose of GARDASIL the patient fainted.  It was reported that there was no information about the first dose of GARDASIL.  The patient sought unspecified medical attention.  On an unknown date, the patient recovered.  Additional information has been requested.
Haven?t had my monthly cycle since I?ve had this shot. Was getting my cycle every month since I was 12 years old. My cousin, 5 years younger, has had the same experience. And she got Moderna shot.