chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Tingling sensations in lower right arm and hand; The fingers on right hand can suddenly snap shut/ Snap Finger; The pain in my neck began about 17 to 18 minutes after injection; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Jul2022 as dose 4 (booster), single (Lot number: FN2908) at the age of 71 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Lot Number: EN6201, Anatomical site of vaccine administration: Left arm), administration date: 10Mar2021, for COVID-19 immunization, reaction(s): "Terrible joint pain", "Muscle aches", "Headaches", "Nausea", "Terrible fatigue"; BNT162b2 (DOSE 2, SINGLE, Lot Number: ER8732, Anatomical site of vaccine administration: Left arm), administration date: 31Mar2021, for COVID-19 immunization, reaction(s): "Terrible joint pain", "Muscle aches", "Headaches", "Nausea", "Terrible fatigue"; BNT162b2 (DOSE 3 (BOOSTER), SINGLE, Lot Number: PF2590, Anatomical site of vaccine administration: Left arm), administration date: 21Oct2021, for COVID-19 immunization, reaction(s): "Terrible joint pain", "Muscle aches", "Headaches", "Nausea", "Terrible fatigue". The following information was reported: NECK PAIN (non-serious) with onset 01Jul2022, outcome "not recovered", described as "The pain in my neck began about 17 to 18 minutes after injection"; PARAESTHESIA (non-serious), outcome "not recovered", described as "Tingling sensations in lower right arm and hand"; TRIGGER FINGER (non-serious), outcome "not recovered", described as "The fingers on right hand can suddenly snap shut ". The events "the pain in my neck began about 17 to 18 minutes after injection", "tingling sensations in lower right arm and hand" and "the fingers on right hand can suddenly snap shut " required physician office visit. Therapeutic measures were not taken as a result of neck pain, paraesthesia, trigger finger.  Additional Information: When she went for the second booster, she had reported her previous reactions. The pain in her neck began about 17 to 18 minutes after injection and the reaction was much worse than the prior ones. The fingers on her right hand can suddenly snap shut and she had tingling sensations in her lower right arm and hand. While not as serious as in Jul2022 and Aug2022, she still had difficulties.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300258400 same patient/reporter, different dose/event;
On April 27, after my husband took a 2 mile run.  He returned and collapse outside of our home.   My son and I immediately perform CPR on him.   Three week later my husband did from  respiratory heart failure - cardiac arrest.   He had no complaints about any chest pain ever.  We had just visited his doctor that afternoon and  gave no report of heart problems or any immediate health issues.
The first couple of days I just had a sore arm and then it was normal.   One week later I developed a very sore and slightly swollen underarm and then the next day I still had the sore underarm and then the injection site became itchy.   It is still itchy and red now and my underarm is still swollen and painful.  The site is also warm.
No adverse event; patient received 0.5 ml the Moderna booster as opposed to the bivalent; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (patient received 0.5 ml the Moderna booster as opposed to the bivalent) and NO ADVERSE EVENT (No adverse event) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Oct-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milligram. On 06-Oct-2022, the patient experienced WRONG PRODUCT ADMINISTERED (patient received 0.5 ml the Moderna booster as opposed to the bivalent). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (patient received 0.5 ml the Moderna booster as opposed to the bivalent) 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 WRONG PRODUCT ADMINISTERED (patient received 0.5 ml the Moderna booster as opposed to the bivalent).    Concomitant medications were not reported.  The patient's Covid 19 vaccination history was unavailable.  No treatment information was provided by the reporter.
Information has been received from a physician referring to a patient of unknown age and gender. Information about medical history, concurrent condition and concomitant medication was not reported. On 14-OCT-2015 the patient was vaccinated with a dose of improperly stored ROTATEQ (lot # L008031 with expiration date of 03-AUG-2015, strength, dosage and frequency unspecified (incorrect product storage). No adverse symptoms were reported. This is one of several reports received from the same reporter.  Additional information has been requested.
Throbbing in deltoid area on and off.  Heaviness and pain from left deltoid region extending to left palm intermittent since getting FLUZONE.  Once above where injection was asymptomatic.
Patient received her vaccination in the late afternoon on 6/5/19.  She started to develop swelling and  redness on her arm that spread from the injection site on her  around to the underside of her arm.  She contacted me on 6/6/19 to report this to me and to ask what she should do.  I had requested the patient to stop by the pharmacy so I could access her arm, but she stated she wasn't nearby and could not come in.  I asked her if she had any shortness of breath or swelling on her face/tongue/lips, she stated no.  I advised her to try to take Zyrtec to see if it helped with the itching (I decided against Benadryl due to her age and psychiatric medications/psychiatric history- it is very sedating) and to follow up with the pharmacy to let us know if it got any worse.  Patient contacted the other pharmacist at my pharmacy, on 6/7/19, to report increased arm pain and fever.  She went over the possible adverse reactions to the vaccine.  Patient did not seem overly concerned or upset, she was just wondering how to proceed.  Patient went to urgent care on 6/8/19 and was told by urgent care that she had Post-Injection Inflammatory Reaction and cellulitis.
Patient reported that he is currently immobile and has missed work since November due to his symptoms.  Patient was recently diagnosed with Ulcerative Colitis but noted that doctors had a difficult time diagnosing his illness and initially suspected salmonella was causing his symptoms.  Patient has been taking Prednisone 40mg daily and was recently diagnosed with and treated for a blood clot in his leg earlier this week on Monday, although he had been experiencing pain in his leg for a couple of weeks prior to this diagnosis and noted that he had a history of blood clots.  Patient reported that he received the J&J COVID19 vaccination on November 23, 2021 at Pharmacy.  Lot#Z13D21A.
Information has been received from a physician concerning a female who on approximately 05-JUN-2007 was vaccinated with a 0.65 ml dose of Zostavax (Oka/Merck).  On approximately 05-JUN-2007 the patient developed a red, itchy, and swollen injection site.  Unspecified medical attention was sought.  Subsequently, the patient recovered.  No further information was provided.  There was no product quality complaint involved.  Additional information has been requested.
Felt skin sensitivity and soreness along torso, back and underarms starting possibly that night, definitely by following morning. Presented with rash on lower right back, which has spread around to the lower right stomach. Diagnosed as shingles.
This spontaneous report as received from a consumer refers to one of her 3 grandchildren of unknown age. It was reported that the patient may have received GARDASIL (lot # not reported) outside of the closing schedule. The reporter was unaware of the dates when the patient received the GARDASIL injections. No adverse effect reported. Whether the patient sought for medical attention was not reported. This is one of several reports received from the same source. Additional information has been requested.
arm is red; arm is swollen; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (arm is red) and PERIPHERAL SWELLING (arm is swollen) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) unknown. On an unknown date, the patient experienced ERYTHEMA (arm is red) and PERIPHERAL SWELLING (arm is swollen). At the time of the report, ERYTHEMA (arm is red) and PERIPHERAL SWELLING (arm is swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  Treatment information was not provided.
Hip Rash; blisters; tender rash; Rib Cage Soreness; Sore arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 53-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 28th June 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 28th June 2019, less than a day after receiving Shingrix, the patient experienced pain in arm. On 29th June 2019, the patient experienced intercostal myalgia. On 1st July 2019, the patient experienced red rash, blister and painful rash. On an unknown date, the outcome of the pain in arm, red rash, blister and painful rash were not recovered/not resolved and the outcome of the intercostal myalgia was unknown.   It was unknown if the reporter considered the pain in arm, intercostal myalgia, red rash, blister and painful rash to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix vaccine in left arm and reported a sore arm following vaccine that was still currently sore on the day of reporting. In the night after vaccination caller reported during the middle of the night soreness in the muscles surrounding rib cage (left and right rib cages). In the morning of day of reporting, caller reported waking up with a tender red rash on her hip with three blisters in the middle. Rash was roughly the size of a quarter. The reporter gave consent to follow up. Caller mentioned having a picture of the rash. No protocol was available concerning how to obtain picture from consumer to include in letter to healthcare professional. There was discrepancy between the outcome reported in the structured field (not recovered) and the outcome reported in the source document (recovering).
I had started having severe abdominal pain on 07/22/2021. And it got worse, so I went to the ER and they did a CAT scan and it said that both of my ovaries were prominently sized especially the right ovary being enlarged. I did have a follow up with my PCP and she ordered an ultrasound. When I went to have that done, it went back down to normal size.
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient (company representative), a 30 year old female of unspecified ethnic origin. Initial information was processed with additional information received on 16-MAY-2022. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient previously received first dose of covid-19 vaccine ad26. cov2. s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: 043A21A, expiry: 16-FEB-2022) dose was not reported, 1 total administered in the right arm on 08-APR-2021 for prophylactic vaccination. It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26. cov2.s (dose number in series 1). The patient additionally received booster dose of covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin not reported, batch number: 204B21A, expiry: unknown) dose was not reported, 1 total administered on 30-NOV-2021 (possibly in left arm but reporter was unsure) for prophylactic vaccination. No concomitant medications were reported. The patient reported her symptoms included vomiting, diarrhea, lethargy, small headache and flu like symptoms. The patient reported she tested covid positive on a rapid test as of 31-JAN-2022 (suspected covid-19 infection) (dose number in series 2). The patient developed COVID-19 as of 31-JAN-2022 which resulted in suspected clinical vaccination failure (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from suspected covid-19 infection, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000231044.; Sender's Comments: V0: 20220528464- Covid-19 vaccine ad26.cov2.s-suspected clinical vaccination failure . The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
Swelling and redness at injection site, deltoid swollen to 2-3 times normal size Itching at injection site, slight rash Soreness in armpit on same side as injection site Joint pain and fatigue
Initial misuse report received from a healthcare professional on 11 November 2013. The case is invalid as the individual patient identifiers were not reported. It was reported that 5 pregnant women had received FLUZONE HD. No adverse event was reported. List of documents held by sender: none.
mom states pt was immunized @ 5PM on 6MAR96;6PM devel muscle spasms & body jerking then passed out p/sleeping for 30mins;pt awake lethargic treated in ER 6MAR96 vs t40R-160-28;
redness @ inj site in < 1hr p/inj; p/48hrs still red, firm, sl warmth, sl tenderness; tx for early abscess;
Lower back pain in the Kidney area. Tender to touch and movement in the Kidney location.
21 year old male presented for second dose Pfizer developed chest pain within 15 mins of vaccination that escalated to headache in addition to chest pain within the following 5 mins.
This spontaneous report as received from a nurse practitioner refers to a 13 year old male patient with no pertinent medical history nor drug reaction/allergies. On 04-AUG-2015, the patient was vaccinated with GARDASIL lot # L018286, expiration date 13-APR-2017 (dose and route were not reported). There was no concomitant therapy. On 04-AUG-2015, the patient experienced light-headedness and repositioned himself to the floor of the room. The patient was repositioned by nursing staff to a supine position. His blood pressure was measured and after he lost consciousness, was lower than it had been before he received the dose of GARDASIL. After an unspecified period of time, the patient was able to sit upright. He received some juice, and then he received one other unspecified vaccination. He did not experience any "light-headedness" after he received the second unspecified vaccination. The patient was released to home after this experience. The outcome of hypotension and dizziness was reported as recovered on 04-AUG-2015. The causality was not reported. This is one of several reports received from the same source. Additional information has been requested.
Covid rebound after finishing Paxlovid; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Covid rebound after finishing Paxlovid) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Obesity, Depression and Penicillin allergy. Concomitant products included NIRMATRELVIR, RITONAVIR (PAXLOVID) from 10-May-2022 to 15-May-2022 for COVID-19 treatment, SERTRALINE, VITAMIN D NOS and MULTIVITAMIN [VITAMINS NOS] for an unknown indication.    On 03-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Covid rebound after finishing Paxlovid). At the time of the report, COVID-19 (Covid rebound after finishing Paxlovid) outcome was unknown. Not Provided          It was reported that patient had not find vaccine card at that moment.  Company Comment: This spontaneous case concerns a patient of an unknown age and gender with no relevant medical history who experienced the unexpected non-serious AESI of COVID-19 unspecified days after the third dose mRNA-1273 vaccine. It was reported that patient had Covid rebound after finishing Paxlovid treatment regimen. COVID-19 pandemic could be confounding for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a patient of an unknown age and gender with no relevant medical history who experienced the unexpected non-serious AESI of COVID-19 unspecified days after the third dose mRNA-1273 vaccine. It was reported that patient had Covid rebound after finishing Paxlovid treatment regimen. COVID-19 pandemic could be confounding for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.
sore arm; red area; 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.   Previously administered products included Shingles vaccine with an associated reaction of pain in extremity (1st dose received on an unknown date, refer case US2022AMR083982).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain in arm and erythema. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the pain in arm and erythema were unknown.   It was unknown if the reporter considered the pain in arm and erythema to be related to Shingles vaccine.     Linked case(s) involving the same patient:  US2022AMR083982   Additional Information: GSK Receipt Date: 22-MAY-2022 Reporter's Comment: The patient self-reported this case via interactive digital media. The patient received dose of Shingles vaccine and experienced sore arm and red area. The patient was so relieved that he/she got it. The patient further stated it was much better than having shingles. Additional supportive information: The follow-up would not possible, as no contact, details were available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR083982:Same reporter
Dizzy; Headache; I can't see clear; blurry; I cannot walk normal, I am changing lane if I am walking; it's like I'm driving it's like I am changing lanes/cannot drive and I have to come back; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 30Apr2021 (Lot number: EW0171) at the age of 66 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Blood pressure high" (unspecified if ongoing). Concomitant medication(s) included: AMLODIPINE taken for hypertension. Vaccination history included: Bnt162b2 (Dose 1, lot number: EP7533, Date: 02Apr2021, Anatomical site of vaccination: left arm), administration date: 02Apr2021, for COVID-19 immunization. The following information was reported: DIZZINESS (non-serious) with onset 01May2021 11:30, outcome "unknown", described as "Dizzy"; HEADACHE (non-serious) with onset 01May2021 11:30, outcome "recovered" (May2021), described as "Headache"; VISION BLURRED (non-serious) with onset 01May2021 11:30, outcome "unknown", described as "I can't see clear; blurry"; GAIT DISTURBANCE (non-serious) with onset 01May2021, outcome "unknown", described as "I cannot walk normal, I am changing lane if I am walking"; IMPAIRED DRIVING ABILITY (non-serious) with onset May2021, outcome "unknown", described as "it's like I'm driving it's like I am changing lanes/cannot drive and I have to come back". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of headache.  Additional information: Patient took the second dose on 30Apr2021, Friday and then after that she was fine and starting Saturday 11:30 in the morning she felt dizzy and 'blurred' like headache. So, patient had the headache for 3 days and took Tylenol (treatment) and finally the headache goes away but patient was slight blurred. Patient couldn't see clear and on unspecified date in May2021 in the morning patient had to go to work and she had to come back home and it was like she was driving like changing lanes, like she was dizzy. Patient could not drive and returned to home. So, she just want to know if it is okay for a side effect like that or what should she do. Patient had the second dose and had been sick since the second one and wanted to know if it's a case of side effect and how long will it stay with her. Dose of Amlodipine was reported as "10/20 mg" (No further information). Laboratory test: Patient had blood test and everything was okay. It was confirmed that no other treatment was taken. Patient mentioned someone has to call her back and let her know or ask her how she was feeling, and they need to know what was going on with patients.  No follow-up attempts are possible. No further information is expected.
Initial 24 hrs: Injection site pain, slight headache and slight nausea;  After 24 hrs through 72 hrs: fatigue/tiredness, headache, nausea, muscle pain, chills, fever (100.5 deg), significant joint pain
Headache & feeling hot 5-10mins p/MMR cont to have h/a & feeling hot approx 1 hr p/MMR vomited x 1;
This case was considered medically important (OMIC). Information regarding Prevenar (pneumococcal 7-valent conjugate vaccine (diphtheria crm197 protein) injection) was received from a healthcare professional regarding an 18 month old patient who experienced anaphylactic shock. The patient received the second dose on an unspecified date. Relevant medical history was not provided. Indication for Prevnar was immunization. Product was administered on an unspecified date. Dose regimen was 1 dose intramuscular. Concomitant medications were not reported. The patient experienced anaphylactic (anaphylactic shock) on an unspecified date. No additional information was available at the time of this report.
Had a very slight ache in back of neck about 30 min after shot.  About 4-5 hours later my glands leading from the neck to my ears on both sides felt slightly swollen.   It was not painful, but noticeable - sort of how you feel when you can tell a cold is coming on.  My tongue also felt slightly swollen and a little bit of dry mouth.  symptoms disappeared   By the next day.