chrisvoncsefalvay/vaers-outcomes huggingface dataset:
twitching in leg has increased; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Leukemia" (unspecified if ongoing); "stem cell transplant" (unspecified if ongoing); "twitching and intense leg cramps" (unspecified if ongoing); "twitching and intense leg cramps" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: CONDITION AGGRAVATED (non-serious) with onset 02Apr2021, outcome "unknown", described as "twitching in leg has increased".  Additional information: Patient had Leukemia and stem cell transplant and has twitching and intense leg cramps. Had first covid shot  already, second one coming up tomorrow. After first shot, the twitching in leg has increased. Cautions about taking second covid shot.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Rash up to the shoulder of injected arm; blistering of the skin near injection site; swelling of injected arm as well as lips; Rash up to the shoulder of injected arm, blistering of the skin near injection site as well as on the lips, swelling of injected arm as well as lips; Rash up to the shoulder of injected arm, blistering of the skin near injection site as well as on the lips, swelling of injected arm as well as lips; This is a spontaneous report from a contactable physician via Pfizer sales representative.   A 66-year-old female patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) (Lot # CD0412), via an unspecified route of administration at single dose on 05Dec2019 for immunisation. Medical history included diabetes. Concomitant medications were not reported. After receiving the vaccine patient returned to physician's office several days later on 11Dec2019 with adverse effects. Patient experienced rash up to the shoulder of injected arm, blistering of the skin near injection site as well as on the lips, swelling of injected arm as well as lips on an unspecified date in Dec2019 with outcome of unknown.
Initial information received on 14-Aug-2018 regarding an unsolicited valid non-serious case received from non-healthcare professional. This case was linked with 2018SA226678, 2018SA226687 and 2018SA226689. This case involves a 17 years old female patient who administered MENACTRA for which shipment was received at 3 days instead of 2 days and administered, while she received vaccine MENACTRA and TRUMENBA in the same visit. The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 10-Aug-2018, the patient received 0.5 ml second dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot U6016AA, expiry date- 09 Oct 2019 in the right deltoid. It was a case of actual medication error due to Deteriorated drug administered. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 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.
Headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 8 year-old male patient received bnt162b2 (BNT162B2), administration date 30Dec2021 (Lot number: FL8095) at the age of 8 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 1, Lot Number: FK5618, NDC and Expiry Dates for the patient's vaccines are unknown), administration date: 09Dec2021, when the patient was 8 years old, for COVID-19 Immunisation. The following information was reported: HEADACHE (non-serious) with onset 31Dec2021, outcome "not recovered", described as "Headache".  Additional Information: Caller states that she was calling about the shot that her 8 year old son got the second dose of yesterday. States that her son had a headache now and she wants to know if he can take Tylenol. Caller denies any other medication, medical conditions, labs, testing, or treatments for her son relevant to these events. No There were no other products, patient history and investigation assessment  No follow-up attempts are possible. No further information is expected
pt recv vax feb1999 & 3-5 days following pt exp a breakthrough rash of the classic type w/at least 12  varicella lesions, fever 102f. pt treated w/acyclovir.
11/4 Right arm swollen, red, hot from shoulder to elbow.  11/5 Increased swelling, same redness.  Afebrile.  Axilla/lymphadenopathy, decreased pain.  Cellulitis vs vaccine reaction, clindamycin po.  Recovering.
This spontaneous report as received from a pharmacist refers to a 50 year old male patient with no known drug reactions/allergies. Medical history included shingles. On 15-OCT-2013, the patient was vaccinated with ZOSTAVAX (lot # J004311, exp. Date: 12-JUL-2014) 0.65 ml, subcutaneous. Concomitant therapies included Flexeril, Lisinopril (manufacturer unknown), Reglan, Celecoxib, Oxycodone, Diazepam, Lexapro and Ambien. On 15-OCT-2013, the patient developed a mild case of shingles. On an unknown date, the patient sought medical attention by office visit. No laboratory tests were performed. The patient was given Acyclovir as treatment for the event. On an unknown date, the patient recovered from shingles. Additional information has been requested.
Red splotchy rash around where the vaccine was admistered.  It was hot and looked like a whelp.
10/9/03 client states shoulder areas were sore post flu shot and just never got better. 10/21/03 seen by a family doctor for continued shoulder pain. See attached notes Dr does not feel this is related to the flu vaccine client has rheumatoid arthritis.
Within a few days, post vax of 5th Anthrax shot, on 3/1/00, I began experiencing fairly severe joint pain at the base of my right thumb (where it joins my hand). It continues to this day. In early April, 2000, flight surgeon looked at my thumb and determined it was not bruised, strained or pulled.
Soreness at injection site / If the area is touched it feels tender; This case was reported by a consumer and described the occurrence of injection site pain in a 89-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was not recovered/not resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and experienced soreness at the injection site.  The reporter reported if the area was touched not, it felt tender. The reporter consented to follow up. This case linked with US2021005938 and US2021005937, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021005938:Same reporter US-GLAXOSMITHKLINE-US2021005937:Same reporter
Pt recvd vax in PM & was given fever meds when arrived home; pt slept for long period woke up screaming & screamed most of 2 days, did not eat well-was not consolable;
Having pings and needles feeling my legs and hands; This case was reported by a consumer via interactive digital media and described the occurrence of puncture site pain 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 puncture site pain. On an unknown date, the outcome of the puncture site pain was unknown.   It was unknown if the reporter considered the puncture site pain to be related to Shingles vaccine.  Additional details were provided as follows: Age at vaccination was not reported. The patient received Shingles vaccine and experienced pins and needles feeling in legs and hands. The patient asked was that common.
Patient developed dialated pupils and rapid heart rate.  She became somewhat unresponsive, but remained upright. After becoming responsive the patient stated they were dizzy and have vision and hearing issues during the event.
After I was vaccinated the second time I started with this symptoms that I never have before. The symptoms were I felt very red in my face, headache and shortness of breath with an elevated pulse rate. After the second dose I had three events and after the third dose (booster) I had five more events. I had to go to emergency room and I has been evaluated by my primary doctor and cardiologist. They have not found the cause. I need you to let me know if there has been reported .
Initial nausea and lightheadedness, followed by headaches day of shot and next day. 2 days after shot incredible dizziness in the a.m.  1 hour after waking which lasted all day. Dizzy sitting and standing. Saw double vision with slight headache. Slight sweating. Not hungry.  Urged to go to ER due to possible stroke; however, all tests proved stroke negative. The dr. finally admitted it was a possible vaccination side effect, which I initially told them it was most likely the cause.
Information has been received from a pharmacist concerning a 67 year old female who on approximately 03-NOV-2008 was vaccinated with PNEUMOVAX 23, 0.5 ml. Concomitant therapy included influenza virus vaccine (unspecified). In November 2008, the patient developed a local swelling and redness at the injection site after receiving a dose of the vaccine. As of 10-NOV-2008, the patient was recovering. The patient was seen by the pharmacist. Additional information has been requested.
4-5 days after vaccine I had shortness of breath and it felt like an elephant was sitting on my chest. Everytime I took a breath I couldn't get a breath in. It felt like I couldn't get but 20% of a breath in. I had that for maybe a day or two and then it went away. I also had spotting immediately after which isn't normal for me, and the morning after is when I started spotting and it wasn't my period.
0700 - Nausea, vomiting, febrile (101.2), lethargy, malaise, headache, chills. 0700 - Promethazine 25 mg, Tylenol 1,000 mg. 1100 - Remained febrile. 1100 - Ibuprofen 400 mg . 1400 -  Nausea, vomiting, fever, headache, & chills resolved.
This spontaneous report was received from a physician via a company representative, and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and drug reactions/allergies were not reported. On 19-APR-2016, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 "10 PK SD-PFS LLok w Tip", 0.5 ml, lot # L007720 with expiration date of 08-JUL-2016 (strength, route of administration were not reported). No concomitant medications were reported. No adverse effects and no product quality complaints were involved. On an unknown date, the vaccine was stored at a refrigerator and the longest reported temperature excursion lasted 192 hours, with a lowest recorded temperature of 1 F (also reported as 1 Celsius degree). There were also another excursions on unknown dates which lasted 100, 96, 24 and 24 hours with lowest recorded temperatures of 34 F (reported as 1.111111111 Celsius degrees), -1 F (also reported as -1 Celsius degree), 32 F (reported as 0 Celsius degrees) and 0 F (also reported as 0 Celsius degrees), respectively. The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator (R)". This is one of several cases received from the same reporter. Additional information has been requested.
COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient.  A 45-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Other medication in 2 weeks was received.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
I am not, just having bad, my mouth is moving out of control, it was like wiggling and stopping; I had like a headache on my left side.; inside of my mouth just started moving; It scared me; had side of my face was sore; I had my head hurt and I am like, my neck, oh my god, what's going on; I had my head hurt and I am like, my neck, oh my god, what's going on; it's wiggling like it and  while I am breathing there is a time I go like (consumer imitates like breath-ing is stopped) and then breathing normally; This is a spontaneous report from contactable consumer (patient). A 65-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: ER8732 and expiration date was not reported), dose 2 via an unspecified route of administration, in left arm on 02Apr2021 as SINGLE DOSE for COVID-19 immunization. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number and expiration date was not reported), via an unspecified route of administration, on an unknown date as SINGLE DOSE for COVID-19 immunization. The patient's medical history included high blood pressure and Sinus. The patient's concomitant medications included metoprolol (blood pressure), amlodipine (blood pressure), diazepam and gabapentin (problem with my leg). The patient reported on an unknown date, that she was having a reaction and got her second shot over three weeks ago. The patient experience last night was not just having bad, my mouth was moving out of control, it was like wiggling and stopping wiggling and stopping, it did all the night and up my mouth on my left side is moving, it's wiggling like it and  while I am breathing there is a time I go like (consumer imitates like breathing is stopped) and then breathing normally, face just moved on it's own, it did a few time but last night which it, did it to the moment it kept doing it, kept doing it and then had like a headache on my left side. Patient was trying to sleep, for today this morning, inside of my mouth just started moving, You know, fast, fast and air coming out and this woke me up and now things started again and air coming out, oh my god, It scared me and noticed that when I am sitting up or laying it coming up and then it go back to normal. Patient had side of her face was sore and they did it so fast and quick, could hear doing stop and had my head hurt and I am like, my neck, oh my god, what's going on. Patient at the hospital had Ultrasound and X ray done. Patient took Tylenol. The outcome of the events was reported as unknown.      Follow up#1 (PRD 25Apr2021, SRD 26Apr2021): This is a follow up spontaneous report from a 65-year-old female contactable consumer. This consumer (patient) reported information included concomitant medication, medical history, events, outcome, lab data.       Follow up attempts are needed. Further information has been requested.
Fever, won't eat, can barely walk, can't get out of bed, slept for 14hrs!
Area below injection site is warm; lump below injection site; Area below injection site is sore; huge bright red welt below injection site on side of bicep; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Area below injection site is warm), VACCINATION SITE MASS (lump below injection site), VACCINATION SITE PAIN (Area below injection site is sore) and VACCINATION SITE ERYTHEMA (huge bright red welt below injection site on side of bicep) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included Spiriva                                                        bronchial condition and Vitamins                                                       supplement for an unknown indication.    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, the patient experienced VACCINATION SITE WARMTH (Area below injection site is warm), VACCINATION SITE MASS (lump below injection site), VACCINATION SITE PAIN (Area below injection site is sore) and VACCINATION SITE ERYTHEMA (huge bright red welt below injection site on side of bicep). At the time of the report, VACCINATION SITE WARMTH (Area below injection site is warm), VACCINATION SITE MASS (lump below injection site), VACCINATION SITE PAIN (Area below injection site is sore) and VACCINATION SITE ERYTHEMA (huge bright red welt below injection site on side of bicep) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
lymph swelling in the breast; This is a spontaneous report from Pfizer sponsored program. A contactable Other HCP reported for a female patient. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number was not reported) via an unspecified route of administration on an unspecified date as dose number unknown for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced lymph swelling in the breast on an un-specified date. Reported as AE for reports of lymphadenopathy and extended menses in two female recipients of the Pfizer BioNTech Covid-19 Vaccine. Call received as transfer from (name withheld). she is a physical therapist with questions about the Pfizer BioNTech Covid-19 Vaccine. she just had a baby, and she has not gotten vaccinated yet. she knows two other health care providers who have received this vaccine; one of them had lymph swelling in the breast and one of them had an extended period. The clinical outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
7 days after the vaccination, I developed an itchy, red,  rash just below the site of injection, about the size of a nickel. The nurses administering the COVID vaccines suggested that I call the on-call allergist. He said not to worry. He recommended that I take an allergy pill each day until the rash/bump went away. He also said to ice the rash/bump and massage the area. 8 days after the vaccination, the rash welted, remained red and itchy, and grew about 6 times larger than the day before. The nurses administering the COVID vaccine called the same on-call allergist that I spoke to the day before and he recommended to take the allergy pill twice a day and continue the ice and massage of the area. 9 days after the vaccination, the rash started to get better. 10 days after the vaccination, the rash was mostly gone. 11 days after the vaccination, the rash was all gone.
** Hives at site on 4/17, faded and didn't return. 4/26 At 4:30 PM complained of headache and eyes hurting. 5:00 PM fever of 100.4. Fever at highest was 101.2 that evening.  Blank stares noted 3x that evening.  Following morning fever at 100.4 again.  Complaints of weakness and inability to use legs.  * Called nurse advice line said to only monitor.  Was very sleepy and exhausted continued to complain that eyes hurt.  4/28 1:50 AM woke with violent rhythmic convulsing and unique grunting -like noises which lasted for a couple of minutes, fever was taken and was 101.4. 4/29 scheduled DR visit at 9:30.  Woke with rash, had two very evident seizures before appointment.  Had fever of 100.3 at appointment.  Dr. made follow up for EEG. EEG  4/30/15, came back abnormal.  Appointment with pediatric neurologist 5/7/15.  Confirmed Complex partial seizures in frontal lobe, with possible general seizures.  Prescribed Keppra.
Patient reports they were treated in the Emergency Room for muscle weakness, loss of bladder control, chills and vomiting.
Painful axillary lymph node swelling; Painful axillary lymph node swelling; This is a spontaneous report from a contactable physician reporting for himself. A 31-year-old male received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number: ek9231/expiration date: not provided), via intramuscular route of administration, on 06Jan2021 at 08:00 AM (at the age of 31 years old) as a single dose in the left arm for COVID-19 vaccination. Relevant medical history was none. The patient did not have any known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication was not provided. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number/expiration date: not provided), via an unspecified route of administration, on 07Dec2020 at 08:15 AM (at the age of 31 years old) as a single dose for COVID-19 vaccination. The patient did not receive any other vaccines within 4 weeks prior to the second dose of COVID vaccine (except for the first dose of BNT162B2). On 08Jan2021, at 04:00 AM, the patient experienced painful axillary lymph node swelling, ipsilateral to injection. The patient received ibuprofen as treatment for the event painful axillary lymph node swelling. The outcome of the event painful axillary lymph node swelling was recovering. Since the vaccination, the patient had not been tested for COVID-19.
3/8/21 "pts husband called and watns to tlk to Dr to let him know pt got second Moderna vaccine last week, could not rememver what exact day but on 3/5/21, Pt woke up and couldnt swallow and was having diffculty breathing. Taken to Hospital after 911 call."  Original Dx was Mysathenia Gravis per chart, received IVIG therapy.  Was in ICU.Could not walk, swallow and eye sight is failing, was on BIPAP.DCd to SNF on 3/17 for aaprx 5 weeks.  Home x 1 week, severe symptoms returned, readmitted why dysphasia, dyspnea. hypoxia, weakness, DVT, NSTEMI, demand ischemia, neuromuscular disease or syndrome.  Tests: Lumbar puncture, Swallow Eval, blood draws, CT head, IV antibiotics, catheter placement, incon long term urinary incontinence with incont device needed at home.  Leukocytosis, possible Miller Fisher Variant of GBS. EMG, IVIG, steroids XRAYs  catheters. lumbar punctures, full neurological work up, BiPAP  pt has over 30 days of hospitalizations and over 5 weeks of SNF/rehab Lot number of vaccine not available, was not given at this facility.
Headache, shortness of breath, elevated blood pressure, feeling of heaviness. Seen in ER, continued to have increased blood pressure, medicated.  Returned to ER same night for increased blood pressure sent home with treatment.  Saw her regular MD next day.