chrisvoncsefalvay/vaers-outcomes huggingface dataset:
PAIN AT TE INJECTION SITE; REDNESS AT INJECTION SITE; SWELLING; TIRED; MUSCLE ACHES; UPSET STOMACH; headache; This case was reported by a other health professional via call center representative and described the occurrence of injection site burning in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 14th August 2019, the patient received the 1st dose of Shingrix. On 14th August 2019, less than a day after receiving Shingrix, the patient experienced injection site burning, injection site erythema, swelling, tiredness, muscle pain, upset stomach and headache. On an unknown date, the outcome of the injection site burning, injection site erythema, swelling, tiredness, muscle pain, upset stomach and headache were recovering/resolving.   It was unknown if the reporter considered the injection site burning, injection site erythema, swelling, tiredness, muscle pain, upset stomach and headache to be related to Shingrix.  Additional details were provided as follows: The patient received the vaccine the day before reporting and experienced all the side effects listed on the same day. She described the redness as presented at the injection site 1 to 1 inches that traveled down her arm a few inches. It looks like a burn.The pain at the injection site was measured as an 8/10 and then a 6/10. The pain was still present and it was difficult to use her seat belt because it goes over the site. The reporter consented to follow up.
Shingles; Information has been received from a lawyer concerning a case in litigation and refers to a patient of an unknown age and gender. The patient's medical history, historical drugs and concomitant therapies were not reported.   In 2008, the patient was vaccinated with Zoster Vaccine Live (ZOSTAVAX) (dose, route, lot number and expiration date were not reported) for the long-term prevention of shingles and zoster-related conditions.   On an unknown date, subsequent to the vaccination, the patient was treated for shingles. The patient would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications and supplies. The outcome of the event was not recovered, and the causal relationship between the event and Zoster Vaccine Live (ZOSTAVAX) was related.
Patient received the COVID vaccine for ages 12 and up. Not the vaccine for ages 5-11
Dose was administered after expiration time. Vaccine had been diluted for 7.5 hours. Patient had no reaction to vaccine.
Patient was accidentally given LAIV4 and IIV4 same day. No adverse reactions per Mom (9-18/13 at 4:55 pm).
Itchy, and red blotches at injection site. Swollen and very hot. All 10 days later.
Massive headache, fatigue, body ache, fever, chills, nausea, swollen under arm on 10/08/2021
Fever 101.1 F,  mild dry cough, muscle aches, nausea , severe fatigue, headache.
This was my second Moderna vaccine.  I was okay for the first two days and then I became tired, achy, feverish.  All I remember is that I was in bed for about 7 days.  Then on the 8th day, it all went away.  I was talking to a pharmacist on Friday and she told me I needed to report this.
No symptoms or problems but client received 2 influenza vaccines, 2 separate arms at same time during vaccination clinic by 2 nurses.  Vaccines were marked correctly but 1 flu vaccine was set up for sibling.  Both nurses grabbed flu shot, gave at same time.
Patient received an extra dose of DTaP/IPV due to patient's vaccine record not being properly abstracted into the system. Patient had already received a dose on 02/10/2022, which was not needed.
The day after I got my vaccine (a Thursday) my arm hurt really bad, and my body aches started as soon as I woke up, but were not severe. As the day progressed, the body aches got more severe and were accompanied by a headache and fever by around 7 PM. I literally felt like I was dying, and have never had body aches that bad before in my life. I laid on my couch and didn't move until 11 PM, with no apetite, and then went to bed. The day after that, when I woke up the body aches weren't as bad, and my temp was 98.8. Again, around 3 the body aches started getting worse, I was so tired I could barely function, couldn't eat without being nauseous, and laid in bed as still as possible until I could fall asleep. The Saturday following my vaccine, I woke up at 6 and my body hurt so bad it felt like I couldn't move, my head was so bad even the light from the shades felt like it was piercing me, and I still had no apetite. I stayed in bed until 10 until the body aches got a little better, and was able to go about my day almost as normal, just with my body feeling kind of like I slipped and fell on ice. On Sunday, I still had no apetite and was nauseous without even eating. My body still ached, but I was able to do things like the dishes and just hang out at home. My headache was still unbearable. I called the hotline number for my hospital that was given to me when I got my vaccine, and they scheduled a COVID nasal swab test at 1. I put on sunglasses to drive the 10 minutes to the clinic, got my test, and went home and went to bed. Since I had a COVID test ordered by my employer, I wasn't allowed to work until I got the results and HR cleared me. The results were negative, and I didn't get cleared by HR until Monday morning. When I contacted my supervisor, he wanted me to stay home anyway since the body aches (even though they were getting better), fatigue, headache and nausea were still there, regardless of a negative covid test. He was worried I had the flu. I made an appointment with my primary care doctor for 2:10 on Monday, and he told me it was just serum sickness. I went home and went to bed. My body aches and fatigue fully went away by Wednesday, and my headache still remains, on the following Saturday. I haven't had a headache in maybe 5 years.
pt recv vax & 10 to 12 days p/vax pt devel a fever of 103.5, irritability & cervical adenopathy;7-10 days later pt recovered from fever of 103.5, irritability & cervical adenopathy;
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05Mar2021 as dose 1, single (Batch/Lot number: unknown), in right arm, on 27Mar2021 as dose 2, single (Batch/Lot number: unknown), in right arm, on 02Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown), in right arm and as dose 4 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing); "Diabetes" (unspecified if ongoing); "HBP" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN; METFORMIN [METFORMIN HYDROCHLORIDE]; METOPROLOL. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: COVID 19 Treatment; (10Sep2022) Negative, notes: I had a positive test today after testing negative (and having no symptoms) Saturday 10Sep22; (11Sep2022) Positive, notes: I had a positive test today after testing negative (and having no symptoms) Saturday 10Sep22. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Patient received Paxlovid anti-viral COVID 19 treatment.Treatment start date was 02Sep2022 and stop date was 06Sep2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
I did not have an adverse reaction to the Dose 4. I tested positive for Covid 19 on 05/06/2021.
Idiopathic Thrombocytopenia; This is a literature report.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (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: IMMUNE THROMBOCYTOPENIA (medically significant), outcome "unknown", described as "Idiopathic Thrombocytopenia".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information currently available, a causal association between the reported event idiopathic thrombocytopenia and bnt162b2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and investigators, as appropriate.
A large red area surrounding the injection site measuring approximately 3x5 inches with bruising inside. This was not visible until this morning, more than 2 weeks after the first dose of the vaccine.
Patient states that she has a mild fever, headache, injection site soreness and mild nausea
Patient received Moderna Vaccine at Medical Center on 1/6/21. Was told to self schedule 2nd appointment. Unable to self schedule at Medical Center so selected Hospital. Arrived today to receive 2nd vaccine at Hospital and screener was not aware that receiving 2nd vaccine at Hospital was not appropriate especially if first vaccine at Medical Center was Moderna. Hospital does not have Moderna vaccine. Screener printed Pfizer on Vaccine card and patient continued on into the vaccination area were the nurse did not challenge the 2 different vaccines on the card and administered the 2nd dose with the Pfizer product
Pt had 5th vaccination yesterday (first 4 were Pfizer), this was Moderna (unsure if it's bivalent). Pt had arm soreness & lethargy with others. After Moderna booster yesterday, today had onset of atrial fibrillation. Given PO Cardizem 240 mg ER in  ED, labs taken. Briefly in sinus rhythm after arrival then back to AF.
Swollen, Large Red whelp with hard knot inside arm.   Burning and itching sensation. Ibuprofen and ice packs did not improve area.
This spontaneous report as received from a registered nurse refers to an unknown number of patients of unknown age and gender. No relevant medical history or concurrent conditions were reported. On unknown dates, the patients were vaccinated with improperly stored PEDVAXHIB (dose, route, lot# and expiration date were not reported; therapy type: digital data logger). Temperature excursion information was reported as: below 36 Fahrenheit, more than 25 times (unknown by the reporter). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Very light Spotting; Patient received first dose on 02Oct2021 and second dose on 23NOV2021; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 49 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 23Nov2021 (Lot number: FJ1620) at the age of 49 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Hypothyroidism" (unspecified if ongoing), notes: Hypothyroidism; "Menstruation stopped" (unspecified if ongoing), notes: Menstruation stopped. Last period 08Sep. Concomitant medication(s) included: SYNTHROID. Vaccination history included: Bnt162b2 (lot number - EW0196, dose number 1, dose vaccine location - Left arm), administration date: 02Oct2021, when the patient was 49 years old, for COVID-19 immunization. The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 23Nov2021, outcome "unknown", described as "Patient received first dose on 02Oct2021 and second dose on 23NOV2021"; INTERMENSTRUAL BLEEDING (non-serious) with onset 18Dec2021, outcome "not recovered", described as "Very light Spotting". Therapeutic measures were not taken as a result of intermenstrual bleeding.  No follow-up attempts are possible. No further information is expected.
This spontaneous report was received from a immunisation official and refers to multiple unknown patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patients were vaccinated with improperly stored ZOSTAVAX (M027117, expiry date: 26-JUL-2017 and M037654, expiry date: 29-NOV-2017, route of administration not reported). The temperature excursion range was between -14°C to -10°C within 1 hour. Data logger was involved. No adverse effect was noted. This is one of several reports from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1703USA005609: US-009507513-1703USA009917.
arthritis; Shingles; I noticed a rash on my front trunk; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 61-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955), dose 2 via an unspecified route of administration, administered in Arm Right on 07Apr2021 (at the age of 61-years-old) as a single dose for covid-19 immunization. Medical history included breast cancer, ongoing arthritis diagnosed about 10 years ago. The patient's concomitant medications were not reported. The patient did not have any allergies. The patient had no other vaccine within four weeks and no other medications received within 2 weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 07Apr2021, the patient returning from receiving 2nd dose, she noticed a rash on her front trunk (left side). It extended to her spine. She went to an Urgent Care facility on 08Apr2021and was diagnosed with shingles. She had shingles between the first and second doses of the vaccine, states on the online report she did not include something she should have, wanted to add that she has arthritis, diagnosed about 10 years ago. Is not reporting any additional events. The adverse event resulted her to visit emergency room/department or urgent care. Therapeutic measures were taken as a result of rash and shingles with Valtrex as an antifugal and gabapentin for pain. Outcome of the event rash and shingles was resolving and for other was unknown.  No follow-up attempts are needed. No further information is expected.
Developed vertigo and went to doctor on 5/7/2021 and received prescription of Meclizine for dizziness and ondansertron odt for nausea. I am able to function as long as I don?t stand to quickly .
pt devel facial rash, mild urticaria & wheal & flare 30 x 50mm @ site of varivax inj w/in 20min of vax;
Fever of 101F, chills, abdominal pain, fatigue lasting until following morning
Patient received a Flu shot FLUZONE HD and a PREVNAR-13 shot on 10-25-15. Both shots were administered in the left arm due to physical therapy/soreness in the right arm. Patient has had no reaction in the past to Flu shots. She stated that when she awoke today (10/31/15) her arm was bright red and very itchy. She came to the pharmacy to show me and she had a large erythematous area where the shots were given about 5 inches by 2.5 inches oval with warmth. Advised BENADRYL at bedtime.
CONSTIPATION LASTING OVER A WEEK, STRONG HEADACHES FOR A WEEK, SINUS CONGESTION, RASH TYPE SKIN ERUPTIONS ON FACE, REMARKABLY SIZED AND A TYPICAL BOIL TYPE CANKER SORES INSIDE MOUTH.
This spontaneous report as received from a Licensed Practical Nurse refers to a 6 year old twin patient. On 23-AUG-2007, the patient was vaccinated with the first dose of RECOMBIVAX HB (dose, strength and route: not reported). On 12-AUG-2008, the patient was vaccinated with the second dose RECOMBIVAX HB (dose, strength and route: not reported). On 12-SEP-2008 (4 weeks after the second dose), the patient was vaccinated with the third dose of RECOMBIVAX HB (dose, strength and route: not reported). There was not concomitant medication reported. No adverse effects were reported. The Nurse Practitioner stated that the patient was administered RECOMBIVAX HB at another physician's office. She had no record as to whether or not the patient experienced any side effect related to the doses given off schedule. This is one of two reports received from the same source. Additional information has been requested.
Given MMR 02/21/2000 - Developed trunk rash, malaise, low grade fever. Joint pain on 03/07 - seen by physician and given Benadryl, Motrin, and Tagomet.
My first dose for COVID-19 was Jansen. I felt so bad with the Jansen, they gave me Pfizer for my dose 2 & 3. Break through COVID-19 on 12/27/2021 dose 2 Pfizer. I had a sore throat and a 2 days later I had a bad cough, body aches, chills and fatigue. I get tried so much and have to take a nap. Then I thought I had a sinus infection. I was going to get my 3rd dose and the doctor did a CT scan and saw trace swelling called Atelectasis. My liver enzymes keep climbing and he really don't know why. I have retested 3 times since having COVID-19. I believe that I have long COVID-19. I haven't felt good since having this. The doctor had me to quarantine for 20 days.
Pt experienced severe anthralgias and myalgias following vaccine.  Treatment with NSAID and steroids only partially effective.
No effects- reporting only. 4-17-13 I diluted the ZOSTAVAX vaccine w/Tdap (BOOSTRIX) by mistake and gave injection sub q. I informed patient immediately and began called for advise. Merck Glaxo CDC FDA.
I have had an allergy to propylene glycol. I got the first dose of my vaccine I woke up during the night three days after the vaccine. My lips were swelling up and I had a tickling feeling at the back of my throat. My lips were getting bigger and bigger. I went to the ER and I was given prednisone and Benadryl. My symptoms subsided a little but when the prednisone wore off, I started to have lingering symptoms. The symptoms returned and I had another course of prednisone. I still have permanent swelling in my hands five months later which started about two weeks after the vaccine. My fingers are puffy and swollen in both hands. My index fingers are the worst. I have white knuckles.
Two weeks after her first dose she started feeling pain in her leg on left side, excruciating pain.; This is a spontaneous report from a contactable consumer (patient) from a Pfizer-sponsored program. This is the second of two reports.   A 59-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in left upper arm on 09Jun2021 10:30 (Lot Number: EW0191; Expiration Date: 30Sep2021) as single dose (at the age of 59 years old) for COVID-19 immunisation.  Medical history none. There were no concomitant medications. The patient experienced that two weeks after her first dose she started feeling pain in her leg on left side, excruciating pain in Jun2021 with outcome of recovered. The event required a visit to the emergency room and a visit to the physician's office. No treatment was required. She went to the ER and they did a sonogram but did not see a DVT. That's why it took so long to get the second dose since she was concerned. Her leg pain went away. Then she decided to get the second dose and all hell broke loose. The patient underwent lab tests and procedures which included on unknown date electroencephalogram: normal  (it looks like it was normal), electromyogram: normal (it looks like it was normal, ultrasound scan: did not see a DVT.   Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101168866 Same patient/Vaccine, different event, different vaccine dose
Increased pulse, SOB, chest pain. "Coughing up a lot of mucous".
I had the shingles shot and have had shingles twice since then/ Suspected Vaccination failure; have had shingles twice; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure 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 vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional information was provided as follows: The age at vaccination was not reported. The patient took the vaccine and had shingles twice since then. This case was considered as suspected vaccination failure, since the details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were not provided.
Experienced sudden feeling of light-headed ness & racing of heart. Felt as if I were going to faint. Immediately laid on floor with feet elevated, had friend monitor my BP every few minutes for about 45 minutes. Eventually felt better, but still felt off kilter.
Chills, shortness of breath, temp of 101.5 Called and spoke to Dr office on 10/09/2014 to let them know the reaction and was told that if the same symptoms appear on 10/09/14 to go to the ER. At this time patients feels tired.
3-inch redness on arm around area; Hard of hearing; Little swollen; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 24-Feb-2021 and was forwarded to Moderna on 24-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (3-inch redness on arm around area), HYPOACUSIS (Hard of hearing) and SWELLING (Little swollen) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concurrent medical conditions included No adverse event and No adverse event.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (3-inch redness on arm around area), HYPOACUSIS (Hard of hearing) and SWELLING (Little swollen). At the time of the report, VACCINATION SITE ERYTHEMA (3-inch redness on arm around area), HYPOACUSIS (Hard of hearing) and SWELLING (Little swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was not provided. No concomitant information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 26-Feb-2021: No specific follow-up information recorded.