chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Mild rash; Hives; Mild fever; Increased levels of pain; Headache / Severe headaches; Severe dizziness; This case was reported by a consumer via call center representative and described the occurrence of fever in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 21st September 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 5 months after receiving Shingrix, the patient experienced fever, pain, headache, dizziness, rash and hives. On an unknown date, the outcome of the fever, pain, headache and dizziness were recovered/resolved and the outcome of the rash and hives were unknown.   It was unknown if the reporter considered the fever, pain, headache, dizziness, rash and hives to be related to Shingrix.  Additional details were provide as follows: After vaccination, the patient had I had a mild fever, increased levels of pain, headache and severe dizziness, which the patient considered just as extreme case of the possible documented reactions and side effects.  This lasted for 3 days before it subsided.  Until the vaccination, the patient had no health related issues and had lead a normal, healthy life.  Within 10 days, the patient developed a mild rash and hives which has persisted. The patient also had severe headaches since then. For tolerance to 2nd dose refer linked case US2020AMR059714 and US2020AMR059715, reported by the same reporter.
Pt recv vax on 5/19/97; on 8/1/97 pt exp tingling legs then weakness in left leg; dx=multiple sclerosis
On 04/30/08, my primary care physician said I would benefit by getting the Pneumococcal Vaccine due to my Diabetes.  At that time I had no known allergies.  The evening I around the injection site was a nickle sized raised red bump.  The next morning it was the size of a fifty cent piece,red and warm to touch.  Bump was circled with pen to see if it would spread.  The morning after it had spread,became very painful,started to swell and arm could hardly be raised above my head.  Was taken to Emergency Room and was admitted with cellulitis of L-Arm.  I was hospitalized from 05/02/08 to 05/06/08. 7/1/08-records received for DOS 5/2-5/6/08-DC DX cellulitis left arm.presented with C/O swelling, redness induration and pain after receiving pneumonia vaccine on 4/30/08-PE:erythematous area indurated, warm, swollen tender to palpation.
serious pain when moving arm; 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 an unknown date, the patient received Shingles vaccine. On an unknown date, 2 months after receiving Shingles vaccine, the patient experienced pain in arm (serious criteria other: Serious by reporter). On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 26-NOV-2022 Reporter's comment: This case was reported by the patient via interactive digital media. The reporter stated that 2 months after the shot he/she had a serious pain every time he/she moved his/her arm. Additional supportive information: Follow-up would not possible, as no contact, details were available.
pt devel large (approx 30 mins) reddened area w/in 24 hrs of immun on rt thigh; On 29JUN93 reddend area now dec to approx 15mm & blister filled w/yellow fluid; abscess rt thigh; redness on rt leg; rt leg less active than lt side;
Reported by EMS per report from wife that he was "sick after shot" and got worse during the night. Wife found him the following morning cold and pale, pulseless.  Dispatch called at 719AM.  Pt pronounced on the scene and taken to Funeral Home.  Uncertain if Medical Exam is planned
Was not able to get the 2nd dose/ Patient did not receive the second dose of the Moderna COVID-19 vaccine and it has been more than 35 days after the first dose; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Was not able to get the 2nd dose/ Patient did not receive the second dose of the Moderna COVID-19 vaccine and it has been more than 35 days after the first dose) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Was not able to get the 2nd dose/ Patient did not receive the second dose of the Moderna COVID-19 vaccine and it has been more than 35 days after the first dose). On 27-Mar-2021, PRODUCT DOSE OMISSION ISSUE (Was not able to get the 2nd dose/ Patient did not receive the second dose of the Moderna COVID-19 vaccine and it has been more than 35 days after the first dose) had resolved.        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.   No relevant concomitant medications were reported.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 09-Jul-2021: Follow up received included reporter information, patient demographics and vaccine information.
patient tested positive; patient tested positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A female patient received COVID-19 Vaccine - Manufacturer Unknown, as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), 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), outcome "unknown" and all described as "patient tested positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Caller stated the doctor tested her and the patient tested positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Caller was called on behalf of his wife about Paxlovid. Caller stated the doctor tested her and the patient tested positive. Patient takes cough syrup. Caller has heard that there's an EUA for Paxlovid. The caller stated that his wife had received the primary series as well as two booster doses. Caller's wife has an underlying problem and wants to know if Paxlovid will help her. Caller asked, "Is Paxlovid for those who didn't receive the vaccine. Patient was about to get the bivalent booster dose. Caller stated that the patient can't get the booster because she tested positive, and they have to wait for 3 weeks. Caller stated that he was trying to figure out if it was necessary to take Paxlovid even if the patient has been vaccinated and boosted twice. The chance of getting a serious complication was minimal. Caller can't determine if Paxlovid was specifically for those unvaccinated people. Caller wanted to know if one is fully vaccinated. Is Paxlovid going to help. Is it necessary to still take Paxlovid to be fully protected.  The information on the batch/lot number for COVID-19 Vaccine - Manufacturer Unknown has been requested and will be submitted if and when received.
Pt came to pharmacy having previously had 2 doses of Pfizer. She noted symptoms to this vaccine including arm numbness that progressed to half her body. This occurred with the first vaccine and she still had these symptoms when she got the second one. Pfizer doses were administered at a different pharmacy location. The numbness started within 24 hours and lasted for about a month. She had not experienced this with other vaccines and expressed she wanted to try Moderna after having COVID in December. After waiting 15 minutes after we vaccinated her with 0.25 ml Moderna she was noticing some tingles down her arm to her finger tips. I advised her to call a doctor if it does not resolve or progresses. She currently does not have a primary physician. She had no other symptoms to report. I called her about 24 hours after vaccination. She expressed severe arm soreness, a bruise, chills, fatigue, and overall body weakness. She mentioned numbness in her arm and half her face, but she had not noticed it in her leg. We discussed normal symptoms of soreness, fatigue, chills, etc. that should resolve in a day or 2 but that numbness isn't typical. I advised seeking a doctor if it is not improving or progresses.
4-48 hours post administration, experienced headache, body aches, low grade fever, fatigue and injection site soreness. Roughly 48 hours after administration, experienced hives covering the entirety of the anterior thighs bilaterally. 4 days after administration, experienced hot flashes and low grade fever
Decreased hearing, blurred vision, tingling in hands/feet, sharp right lower quadrant pain - hours after vaccine. Ibuprofen for pain.
Muscle pain worse at injection site but whole body, pedal edema, fevers 102-104 X 24 hrs, nausea, vomiting, diarrhea x 60 hrs, redness entire skin, non-productive cough, fatigue, malaise, loss of appetite.
generalized malaise, vomiting, h/a w/in 8hrs of booster dose; recovered in 24hrs;
Info has been received from a registered pharmacist concerning an 83 year old retired male with an allergy to codeine, coronary artery disease, chronic obstructive pulmonary disease and hyperlipidemia who was vaccinated IM in the right deltoid on 11/04/2002 at 10:00 with a second dose of pneumococcal vaccine 23 polyvalent (Lot #643783/0709M). There was no illness at the time of vaccination. In the evening, on 11/07/2002, the pt developed redness and tissue swelling on the right arm between the shoulder and elbow, also noted as cellulitis. The pt was treated in the ER with an unspecified IM antibiotic and cephalexin. There were no diagnostic or laboratory tests performed. The pt recovered on an unknown date. The reporter stated that the physician would like a lot check performed for this lot. The records of testing prior to release of this lot have been checked by Compliance and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. No further info is expected.
The patient reported that he gave his last dose of Humira on 01/01/22 and received his second dose of his covid shot on 01/03/22. He stated that he had a small spot of psoriasis reappear that is about the size of a pimple.
her IGG area showed low; she went for her 2nd shot and she still had the pain in her jaw and she thought it might be a little infraction with the tooth and she still thinks that is the case; she went for her 2nd shot and she still had the pain in her jaw and she thought it might be a little infraction with the tooth and she still thinks that is the case; This is a spontaneous report from a contactable consumer (patient). A 74-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EL9266; Expiration Date: 31May2021), via an unspecified route of administration on 17Feb2021 as dose 2, single for covid-19 immunisation. Medical history included ongoing pre-existing infection that went bonkers, severe emphysema, lupus, Chronic obstructive pulmonary disease and tooth extraction at the very end of Dec2020 (patients tooth broke at the gum line and they had to wiggle and bounce it and when it came out it was blackish). States it was from the gum down into the tooth and they had to fight to get it out and she had ongoing pain her in jaw and didn't pay it attention she thought about the extraction. The patient was on steroids for years and years and got into emphysema and on more steroids. She has been on steroids so long taking them and her body is falling apart and it's affecting her teeth. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EL9262, Expiration Date: 31May2021), via an unspecified route of administration on 28Jan2021 as dose 1, single for covid-19 immunisation and experienced face was swollen and it made her nose go crooked with pain in her mouth that was terrible, cellulitis in her face, white blood count was 20 and should have been 10, jaw pain. States she went for her 2nd shot and she still had the pain in her jaw and she thought it might be a little infraction with the tooth and she still thinks that is the case. She stated the 2nd shot was no big deal, you hear people complaining about being tired and chills and she didn't have that and her arm didn't hurt. She stated the worst part is the opposite side of the top of her jaw bone, the 1st time it was the right side, and right now it's the tooth on the left side, the same tooth opposite side. States it broke away from the gum and it's the exact same thing. States when she does go get it done, she is a little leery of going to get that half tooth or if it comes out and fight to get the bottom that is in the jaw and this is probably black with her staying on steroids for years and years and got into emphysema and on more steroids. After the second dose, patients Immune was low and IGG area showed low, so the patient wanted the test and was waiting for the result. She states that her immunity in general has been in a question for a while. Patient had an antibody test and no antibodies even though she got 2 shots. Patient wanted to know under the circumstances will it be in vain and get the 3rd dose. The outcome of the events was unknown.
Redness right leg at injection site 7 cm long x 3.5 cm, tender to touch and hot.
Both of them had an immediate reaction which is "a little arm pain"; Red blotch below the injection site/ red blotch is 4-5 inches long, and 3 inches wide. It is warm to  the touch; Red blotch below the injection site/ red blotch is 4-5 inches long, and 3 inches wide. It is warm to  the touch; This is a spontaneous report from a contactable consumer. This consumer reported for a Female patient (Mother).   A 93-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on 29Jan2021, as a single dose for COVID-19 immunization. The patient's medical history included penicillin allergy, allergies: Neosporin, and allergic to sulfa. Concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on an unspecified date, as a single dose for COVID-19 immunization and they both doses had an immediate reaction which was "a little arm pain" and it's already gone, and they weren't concerned about it already. A couple of days after (no date specified), the patient developed a red blotch below the injection site. The red blotch was 4-5 inches long, and 3 inches wide. It was warm to the touch. It has been a week now, and they said it was not going away. The patient concerned about the blotch on her arm. It was a couple of inches below the injection site. The patient said the blotch didn't hurt. She would just like to get over to medical information to ask them. She didn't feel like it was a life-or-death situation so she would just like more information. She said that it was raised and didn't hurt but warm to the touch. She wanted to know if there a have been reports about this in the clinical trials. She wanted to know if it was in the Pfizer vaccine. Outcome of the events was unknown.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
feeling unwell; fatigued; a little achy; This is a spontaneous report from a contactable consumer. A 36-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the left arm on 12Apr2021 at 15:00 (at the age of 36-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient did not have any known allergies.. 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.  The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the left arm on 23Mar2021 (at the age of 36-year-old) as a single dose for COVID-19 immunisation. On 13Apr2021 the patient was "generally feeling unwell the day after the shot, fatigued and a little achy". The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. The clinical outcomes of the events feeling unwell, fatigued and a little achy were not recovered at the time of the report.  No follow-up attempts are needed. No further information is expected.
Sore arm. Pregnant; due date June 16, 2021. First time mom at the age of 40. First pregnancy.
On Second day 8/3 per mother broke out in Rash both thighs, itchy, no fever no trouble breathing Seen in office 8/6 Rx Benadryl, calamine, hydrocortisone cream Rash was resolving blanches
Received first primary series dose but are now outside the 1-month window for a second primary series dose/ Received primary dose on 30J-an-2023, and needs second dose but can't find it.; no adverse event; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PRODUCT ADMINISTRATION INTERRUPTED (Received first primary series dose but are now outside the 1-month window for a second primary series dose/ Received primary dose on 30J-an-2023, and needs second dose but can't find it.) and NO ADVERSE EVENT (no adverse event) in a child male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On 30-Jan-2023, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTRATION INTERRUPTED (Received first primary series dose but are now outside the 1-month window for a second primary series dose/ Received primary dose on 30J-an-2023, and needs second dose but can't find it.) and NO ADVERSE EVENT (no adverse event). At the time of the report, PRODUCT ADMINISTRATION INTERRUPTED (Received first primary series dose but are now outside the 1-month window for a second primary series dose/ Received primary dose on 30J-an-2023, and needs second dose but can't find it.) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for PRODUCT ADMINISTRATION INTERRUPTED (Received first primary series dose but are now outside the 1-month window for a second primary series dose/ Received primary dose on 30J-an-2023, and needs second dose but can't find it.).    No concomitant medications were reported.  No treatment information was provided.   Reporter did not allow further contact
No rash, but itchy skin, low grade fever, swelling around the eyes, sore arm. Dr. prescribed orthotamivir and Benadryl.
Approximately 2 1/2 days after Shingrix injection (3am on 12/24/21) I woke up from sleep in pain as my right shoulder and right arm went numb. I still have some numbness & cannot move my right arm Upward or Outward more than a few inches. On my 1/11/21 visit to nerve specialist he diagnosed Parsonage-Turner Syndrome. I am undergoing Physical Therapy treatment to try to regain range of motion and then build up muscle again as I have atrophy.
Expired Havrix dose was given; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 16-year-old female patient who received HAV (Havrix 720) (batch number YG7YJ, expiry date 03-FEB-2023) for prophylaxis.   On 14-APR-2023, the patient received the 2nd dose of Havrix 720 (intramuscular). On 14-APR-2023, an unknown time after receiving Havrix 720, the patient experienced expired vaccine used (Verbatim: Expired Havrix dose was given). The outcome of the expired vaccine used 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: 17-APR-2023 The healthcare professional called to report that an expired Havrix dose was given. The reporter requested guidance on how to proceed with patient.  The reporter was provided with medical information telephone number and transferred to medical Information department for help.  The reporter consented to follow up. The patient received an expired Havrix dose, which led to expired vaccine used.
after my initial vaccination approx. 2-3 weeks after I had my first mensuration since getting the vaccination: For my initial mensuration I hemorrhaged for 3 days which is something that I had never had before in my life.  one January 11th 2021 I received my second dose of the vaccine Pfizer lot number EL3249 in my Left arm IM.  Since having the complete vaccination series I have had monthly changed to my mensuration, the time in-between is different monthly and monthly I am hemorrhaging. I have had blood work done for Cancer markers and basic labs that shown nothing. This is an issues that came up with in weeks of receiving the vaccination and initial there was not  a relation between the two. it wasn't until end of 2020 that repots started to come in that more and more women were having similar issues.
3 hours after injection, fever to 103 degrees F with body aches and lethargy.
skipped one menstrual cycle; having a period lasting for 3 weeks; This is a spontaneous report from a contactable other healthcare professional (patient). A 45-years-old non pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: not reported, Expiry date: not reported), via intramuscular route of administration in right arm on 02Apr2021 15:00 (at age of 45-years-old) as dose 2, single for covid-19 immunisation in public health clinic. The patient medical history was not reported. Patient had no known allergies and no other medical history. There were no concomitant medications. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: not reported, Expiration date: not reported), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. The patient had not received any other vaccine within 4 weeks. The patient had not received any other medications within 2 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not tested for COVID-19. On an unspecified date in May2021, the patient skipped one menstrual cycle and then having a period lasting for 3 weeks. No therapeutic measures were taken. The outcome of the events skipped one menstrual cycle and then having a period lasting for 3 weeks was unknown.    Information about lot/batch number has been requested.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.