chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a pharmacist referring to a 75 year old female patient. Information about patient's medical history, concurrent conditions and concomitant medications was not reported. The pharmacist reported that on an unknown date, while the patient was receiving ZOSTAVAX (lot#, dose and route not reported), there was difficulty withdrawing ZOTAVAX from vial after adding diluent. The product leaked out of the top portion of the vial and also "sprayed" from the top. As a result, the patient missed a dose. No adverse events were reported. Product quality complaint (PQC) was involved. The patient did not seek medical attention. Additional information is not expected because there was no consent for follow up.
little bit hurt, painful; headache; couldn't sleep well; left breast swollen; left breast tenderness; was very hot and warm.; This spontaneous case was reported by a consumer and describes the occurrence of BREAST SWELLING (left breast swollen), BREAST TENDERNESS (left breast tenderness), FEELING HOT (was very hot and warm.), PAIN (little bit hurt, painful) and INSOMNIA (couldn't sleep well) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Mar-2021, the patient experienced BREAST SWELLING (left breast swollen), BREAST TENDERNESS (left breast tenderness), FEELING HOT (was very hot and warm.) and INSOMNIA (couldn't sleep well). On 15-Mar-2021, the patient experienced PAIN (little bit hurt, painful) and HEADACHE (headache). At the time of the report, BREAST SWELLING (left breast swollen), BREAST TENDERNESS (left breast tenderness), FEELING HOT (was very hot and warm.), PAIN (little bit hurt, painful), INSOMNIA (couldn't sleep well) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment was reported. No concomitant medication was reported
Cold sores outside of lips and inside my nose rash on my chest and back, rapid heart beat felt like I was going to faint, this happened within 24 hrs of vaccine.
Confirmed clinical vaccination failure/Confirmed covid-19 Infection; Confirmed covid-19 Infection; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 20211263449(0) (Janssen Research & Development, LLC).  A 59 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 05Nov2021 (Batch/Lot number: unknown) as dose 2 (booster), single for covid-19 immunisation; janssen covid-19 vaccine (JANSSEN COVID-19 VACCINE), administered in arm right, administration date 05Apr2021 (Lot number: 043A21A, Expiration Date: 10Sep2021) as dose 1, single for immunisation. Relevant medical history included: "Interchange of vaccine products" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 27Dec2021, outcome "unknown", described as "Confirmed clinical vaccination failure/Confirmed covid-19 Infection"; COVID-19 (medically significant) with onset 27Dec2021, outcome "unknown", described as "Confirmed covid-19 Infection". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (27Dec2021) positive.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Vaccine administered 1/14/03-seen in ER later that evening for fever. WBC 23,000-seen in office 1/15, temp 101.6, sent home. ER again 1/15 WBC 39,000, admitted.
My arm started to hurt sore arm /pain in right arm /right arm has the pain; This is a spontaneous report from a contactable consumer. This female consumer (patient) of unspecified age reported for herself that she received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: UNKNOWN) via an unspecified route of administration into the left arm on 23Jan2021 as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 27Jan2021, this past Saturday, the patient reported that her arm started to hurt, pain in right arm sore arm, which was the opposite of the arm she received the vaccine in. She wanted to know if she could take Aleve for the pain. She did not want to take anything for pain if the COVID-19 Vaccine was still in her system and just wanted to find out if she could take a pain reliever. Outcome of the event was unknown.  Follow up (28Jan2021): This is a follow up spontaneous report from a contactable consumer. This consumer reported which included event and product details.  Information about lot/batch number has been requested.  Follow-up (16Apr2021): 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.
Sore arm; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and FATIGUE (Fatigue) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0112L0A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore arm) and FATIGUE (Fatigue). At the time of the report, PAIN IN EXTREMITY (Sore arm) and FATIGUE (Fatigue) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  No treatment information was provided.    This case was linked to US-MODERNATX, INC.-MOD-2021-004679 (E2B Linked Report).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 03-Jun-2021: Reporter said that her husband is doing fine. Updated outcomes to recovered/resolved. Additional FU declined; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. US-MODERNATX, INC.-MOD-2021-004679:Crosslinked (MOD21-03428)
Information has been received from a MD and a consumer concerning her15 month old son with allergies and a Hx of atopic dermatitis who on 04/12/04 was vaccinated in the left leg with a first dose of varicella virus vaccine live. Concomitant vaccination at the same time included a dose of MMR. In the evening on 04/20/04 the pt developed hives on his inner thighs and was TX with Benadryl., which helped the hives. During the night he woke up and vomited. On 04/21/04 he had a low grade fever of 99.1 and hives on arms, legs and feet. Some were raised and bumpy and some were not. It was reported that the hives were more severe than they were on 04/20/04. The pt's mother stated that she didn't think that it was an allergic rxn to something the pt ate, because no new food was introduced. She reported that at the time of vaccination the MD told her that her son could have a rxn for up to 3 weeks, so she wondered if his hives were from the vaccine that was given 9 days earlier. The pt mother scheduled a DR appt for 04/21/04. The mD felt the pt had hives vs. chicken pox appearance. He felt that the hives were caused by a food allergy to either peaches  or strawberries. The MD statied it was unknwon if the hives were  secondary to varicella virus vaccine live, MMR, or environmental exposure. the pt mother reported the hives improved by the evening of 4/21  and resolved  by 4/22. as of 05/11/04 the pt mother reported she eliminated peaches and strawberries from her son's diet and the hives ahve not reappeared. His fever and vomiting also resolved. She stated that she agreed with teh MD and felt iswas from the food. Additoonal info is not expected.
3 days after my second shot I had an extremely red and swollen arm at the site and all around arm. I also had tightness of my throat and some itching. I went to the ED as it was a Saturday afternoon. I saw a PA. I don?t remember his name. He thought I was having a mild allergic reaction and said the arm was actually a ?normal ? response to Moderna.  They gave me 50 mg Benadryl and watched me for 1hr. My throat improved and I was advised to take Benadryl for the next few days.
Mid November 2022, we were traveling to different sites, and I just stepped over a 6- or 8-inch ledge and fell. It was a pretty bad fall. I have been involved in sports all my life. I feel like I did not react like I should have. I did not feel right after that. I felt like mental fog. I went to see my doctor on November 30, 2022, and we just went over everything. Nothing serious was found. He put me in physical therapy for the fall. I was downplaying it and I felt like I was improving.  I have had probably 3 falls since then the worse being in November2022 and January 2023. Since then, I feel like I am back to 95 percent normal.
Strong shooting pain and aches on left side. From neck, to bicep, to forearm, to buttock, to thigh. Each pain is separate. No shooting pain connecting from neck to thigh, but pain staying in localized areas of each body part. Pain from 4pm-10pm Took 1000mg extra strength Tylenol. Pain still here. But manageable
This non-serious spontaneous case, initially received from other non-health professional on 02-Nov-2018, concerns an 88-year-old, elderly patient of an unspecified gender. It was reported that, the FLUAD (TIV) vaccine underwent temperature excursion for the first time. The vaccine was out for around 48 hours and it reached 11.6 degree Celsius (explicitly coded as incorrect product storage). On 16-Oct-2018, the patient was administered FLUAD (TIV) [route of administration: intramuscular, anatomical location: left deltoid, batch number: 250795, expiry date: 30-Apr-2019 and dose: not reported) which underwent temperature excursion (explicitly coded as drug administration error). At the time of this report, no adverse event was reported. This case 201805471 was crossed linked to original cases 201804863 due to same reporter.
After receiving my 2nd shot my right arm hurt, I had severe headaches and last night (7/28/21) I was up all night due to severe chills. I had a fever of 101 that resolved this morning.  I still have the headaches and arm pain.
Patient was given vaccine 4 days past best use date(expiration date).   Contacted Manufacturer Moderna and received communication that no re-vaccination was necessary.  Vaccine maintained activity for confer protection.
Customer called two days after the vaccination complaining about the pain at the site of vaccination, could not sleep on that side due to unbearable pain. No prior history of any pain related to vaccinations. Came back today (10/22), almost six week later and still complaining of soreness at the site and thinks it might be a muscle damage caused from the vaccine. No visible signs of any damage that could be reported. But insisted I do a reporting on this situation. I have advised her to check with her primary physician and also recommended OTC remedies.
PERMANENTLY DAMAGED; This spontaneous report received from a consumer via a company representative through social media (J and J corporate) concerned multiple patients of an unspecified sex, age, race and ethnicity. The patient's weight, height, and medical history were not reported. The patients received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number and expiry were not reported) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patients experienced permanently damaged (adverse event nos), and was hospitalized (in and out of the hospital constantly). It was reported as "you're pretty clueless to think her hysteria caused her conditions. Just plug along like a good little citizen and ask no questions. Some day, you will wake up because it will happen to you or someone you know. I have friends in and out of the hospital constantly after receiving these vaccines. Some used to think like you. Permanently damaged with no solution in sight. It's the criminal what these companies have gotten away with. But guess what They're making more vaccines because they got away with it and they are looking to do it all over again. In to of that, they can prescribe more drugs to those damaged. More for them". The number of days of hospitalization was not reported and it was unsure if the patients was discharged from the hospital. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of permanently damaged was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0-20221260646- Permanently damaged- Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.
My vaccine was scheduled for 5:00. I had slight dizziness, throat swelling, and uncomfortableness in my arm within the first 15 minutes, though I do not know exactly what time it started. Throat swelling is normal for some of my allergies, so I thought I was fine and went home.  Unfortunately, at home, by 8 PM, my throat had swollen significantly and breathing was more difficult. I took 75 mg of diphenhydramine at around 9 and then went to sleep.  The next morning when I awoke around 9, my throat felt better. I am still a bit dizzy with a feverish feeling and my arm is in significantly more pain that goes almost to my elbow. Some arm pain is normal for vaccination shots for me, though this is more than usual. I do not typically have such significant throat swelling following a vaccine, so I am trying to contact my allergist to see what she thinks about the throat swelling.
Mild rash around site of vaccination and itching. I just want it reported. I understand that 1% have this reaction
This case was reported by a consumer (also the subject) and described the occurrence of throat closing up in a 42-year-old female subject who was vaccinated with Flu vaccine (GlaxoSmithKline). A physician or other health care professional has not verified this report. Concurrent medical conditions included allergy to fish and allergy to molds. On 3 November 2011 at 14:00 the subject received a dose of Flu vaccine (unknown route, left arm). On 3 November 2011, 10 minutes after vaccination with Flu vaccine, the subject experienced throat closing up and rapid pulse. Less than a day after vaccination with Flu vaccine on 03 November 2011, the subject experienced arm soreness and gluteal muscle pain. She also experienced runny nose and stuffy nose. The subject stated that at 24 hours post vaccination, all the events were resolved. She stated that she knows that she received a GSK flu vaccine, but does not know which brand. The subject was treated with liquid BENADRYL. On 4 November 2011, the events were resolved. The subject reported that she had a flu shot approximately a year ago and experienced a weird feeling in her throat and she took BENADRYL as treatment. See A0952703B for details regarding this second case.
Arm has a large bright red, painful but itchy lump that appeared when I got up the next day. The pain is much better but the redness and itchiness haven't changed. This didn't happen with the first two shots.
chills; This is a spontaneous report from a contactable consumer or other non hcp. Consumer reported for himself that a 41-years-old male patient received bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot number: EL3247), dose 1 via an unspecified route of administration, administered in Arm Left on 09Mar2021 09:30 as 1ST DOSE, SINGLE for covid-19 immunisation. Patient did not had any medical history. Concomitant medication(s) included collagen marine, methylsulfonylmethane (MARINE COLLAGEN PEPTIDES WITH MSM); ascorbic acid, euterpe oleracea fruit (ACAI BERRY [ASCORBIC ACID;EUTERPE OLERACEA FRUIT]); vitamin c [ascorbic acid] and vitamin b complex. Patient had no known allergies. On 10Mar2021 07:00, the patient experienced chills. Patient did not received any treatment. It was reported that patient started getting chills almost 24 hrs after getting the first dose, they have lasted for the past 10 hrs. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has been not tested for COVID-19. The outcome of event was not recovered.  No follow-up attempts are possible. No further information is expected.
PATIENT HAD RASHES, THAT LOOKS LIKE A  SHINGLES UNDER HER BREAST AND THE MID-SECTION OF HER TORSO
This spontaneous report as received from a consumer refers to a female patient of unknown age (herself). Patient's medical history was not provided. In 2005 the patient was vaccinated with PNEUMOVAX 23. Patient's concomitant medications were not reported. The patient reported, "I received the PNEUMOVAX 23 vaccine on an unspecified date sometime in 2005 and I need to get it again." The patient then explained, "I experienced many unspecified adverse reactions when I received the vaccine the first time and I don't want to experience it again." The patient confirmed that she had still not yet received a "second injection of PNEUMOVAX 23". The outcome of many unspecified adverse reactions after patient received the vaccine for the first time was unknown. Additional information is not expected.
Patient called via telephone stating he has pain at the injection site and tingling sensation to his fingertips.
4 month old male patient received expired dose of Pentacel was given with no reported adverse event; Initial information received on 23-Jul-2021 regarding an unsolicited non-valid non-serious case from a other health professional via physician (Reference number- 00694718).  This case involves a four month old male patient who was vaccinated with the expired dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL].  Medical history, medical treatment, vaccination and family history were not provided.  Concomitant medications included ROTAVIRUS VACCINE LIVE ORAL 1V (ROTARIX) for Immunisation; and PNEUMOCOCCAL VACCINE CONJ (PNEUMOCOCCAL CONJUGATE VACCINE) for Immunisation.  On 06-Jul-2021, the patient received a 0.5 ml second dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot UJ342AAA and expiry date: 22-Jun-2021) (Frequency: once) via an  intramuscular route in the right thigh (expired product administered) for prophylactic vaccination.  It was an actual medication error case due to expired vaccine used (latency on same day).  It was reported that "Patient Information patient age less than year enter as 2-month 4month etc. Many pediatric vaccines need month for age. Dose: 0.25 mL to 2 mL for vaccines or 0.1 mL for TB (Tuberculosis) skin test-0.5ML, strength: standard except for Fluzone HD-STANDARD , Pregnancy-not applicable, last menstrual period, due date, AE (adverse event) symptoms or no AE, vaccine presentation. If baby was delivered: delivery date and if baby experienced an adverse event, Inform that they will be receiving a follow up questionnaire, If calling specifically about being added to the pregnancy registry: all pregnancy cases are added to the registry, it is an FDA (food drug administration) requirement".  At the time of reporting, no adverse event was reported.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
This case was reported by a other health professional via sales rep and described the occurrence of lethargy in a female patient who received BEXSERO. On an unknown date, the patient received BEXSERO .5 ml. On an unknown date, 1 day after receiving BEXSERO, the patient experienced lethargy, tiredness and injection site pain. On an unknown date, the outcome of the lethargy, tiredness and injection site pain were recovered/resolved. It was unknown if the reporter considered the lethargy, tiredness and injection site pain to be related to BEXSERO. Additional details were received as follows: Medical Science Liaison indicated that an office manager contacted her to report that a female patient (not much info known), no lot, no expiration date, no vaccination date, or age of the patient was vaccinated with BEXSERO, and then the next morning, could not get up, was lethargic and tired for two days; pain at the injection site; stayed home from school for two days. After two days the symptoms resolved. Office manager then mentioned that another patient (see case US2016GSK049200) who received BEXSERO and experienced a softball-like swelling at the injection site. Also mentioned about some other patients (see case US2016GSK049201) who also received a dose of BEXSERO vaccine and felt tired and lethargic for about two days, then the symptoms were resolved. The office manager indicated that she would be happy to be contacted by GSK for more information gathering if needed.
Paralysis on the right side of the face, numbness inside the mouth, swelling of face, lips, throat, and neck.
Patient complained of dizziness immediately after walking to checkout station. We sat him down and he said he was only seeing black and he was got and his neck hurt. We called EMS to check him out also. His BP was 140/90 and his vision started to come back after a couple of minutes as blurry. Once EMS arrived, he was much improved and vitals were all good. He refused to go to the ER, but his roommate assured us that he would watch him today. Patient waited 30 minutes and said he felt totally fine when he left.
no adverse reaction.  patient came to clinic for second dose  and was under age at the time of immunization.  it was noticed at the time of processing paperwor.
Patient left arm is swollen with 3 lumps and hot to the touch.  The swollen goes from top of the injection sight (deltoid muscle) to the elbow. Patient denies fever, or month/ throat involvement
Patient called the day after her vaccination and stated that she had a reaction to the vaccine.  The symptoms started within 24 hours of getting the vaccine.  The symptoms included itchy throat, swelling in her tongue, swelling in her entire right arm that last 2 weeks.  She stated she was taking advil and an antihistamine the entire time.
inflamation, redness,  pain, soreness, warmth to touch at injection site.  An oval shaped area about 3 inches high and 4 inches wide.  I have a photo.
Onset w/t103 ax @ 530PM 19JUL; 7PM devel chills & drowsiness, lethargy & irritability; By 22JUL fever had subsided & rash devel; Continued to be irritable; MD later dx Roseola;