chrisvoncsefalvay/vaers-outcomes huggingface dataset:
the severe neck pain and shoulder pain started a few days, 2 or 3 days after the second shot.; the severe neck pain and shoulder pain started a few days, 2 or 3 days after the second shot.; started having tingling in feet, more like in the right foot.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old male patient received BNT162b2 (BNT162B2), in 2022 as dose 2, single (Batch/Lot number: unknown), in right arm (reported as "right shoulder") for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Anatomical Location: first one was left shoulder), for Covid-19 immunization, reaction(s): "After first shot, 2 days after, started causing him severe neck pain and shoulder pain", "Can not do any exercising at all because of this pain. It has injured his lifestyle", "After first shot, 2 days after, started causing him severe neck pain and shoulder pain". The following information was reported: PARAESTHESIA (non-serious) with onset 2022, outcome "not recovered", described as "started having tingling in feet, more like in the right foot."; NECK PAIN (non-serious), ARTHRALGIA (non-serious) all with onset 2022, outcome "not recovered" and all described as "the severe neck pain and shoulder pain started a few days, 2 or 3 days after the second shot.". Therapeutic measures were not taken as a result of neck pain, arthralgia, paraesthesia.  Additional information: Severe neck pain and shoulder pain started within 2 or 3 days after the second shot. Does not actually remember particularly, when. At first, felt like, was having some little pains, thought he was going to be fine. Also, had another thing he noticed, started having tingling in feet, more like in the right foot. Tingling in feet started same time, after Covid shot. Treatment: No, doctor recommended muscle relaxer, said he would have to pick up medicine again and, if it continues will be looking to recommend some kind of chiropractic thing. Is not a big fan of taking things. Clarified, he took muscle relaxant, did not like how it made him feel, didn't fee like it was doing a whole lot.    The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Pt recv vax on 9/4/97; subsequently pt exp numbness in left side of face & jaw to temple.
Relatively quick development of flu like symptoms, cough, and and subsequent more persistent cough and increasing dyspnea on exertion, ultimately diagnosed is bilateral moderate pulmonary emboli.
Swelling, tenderness over the injection site.  Lymphadenopathy right axilla, tenderness started the next day.
Vaccine was initially stored in the refrigerator on 22-Jun-2023 and vaccine was administered on 25-Jul-2023.; no adverse event; Dose administered after 30-day Use; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use), PRODUCT STORAGE ERROR (Vaccine was initially stored in the refrigerator on 22-Jun-2023 and vaccine was administered on 25-Jul-2023.) and NO ADVERSE EVENT (no adverse event) in a 10-month-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 201L22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 25-Jul-2023, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 25-Jul-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was initially stored in the refrigerator on 22-Jun-2023 and vaccine was administered on 25-Jul-2023.) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use), PRODUCT STORAGE ERROR (Vaccine was initially stored in the refrigerator on 22-Jun-2023 and vaccine was administered on 25-Jul-2023.) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use) and PRODUCT STORAGE ERROR (Vaccine was initially stored in the refrigerator on 22-Jun-2023 and vaccine was administered on 25-Jul-2023.).    Concomitant product use was not provided by the reporter.  Vial was 2.5 ml. Vial did not undergo any temperature excursions. Suspect vaccine expiry date was reported as 06-Sep-2023.  Treatment information was not provided.
I received the second dose of Moderna on 2/18/21 at approximately 1:30 pm. I felt fine the rest of the day but my arm was sore and I wasn't able to sleep on my right side as a result of getting the vaccine in my right deltoid.  It felt like my right arm was attacked by hammers because it was so sore.The next day (2/19/21) I had muscle soreness, chills, and felt tired and "out of it". I took an ibuprofen (400 mg)  at 1:30 pm on 1/19/21 and felt immediately better. My arm where I got the injection was still sore and I noticed when I changed my hosptial scrubs my arm was red and swollen at 3 pm  and had a rash. I took a50 mg  benadryl at 5 pm and woke up and my lips were swollen. I could feel the tip of my tongue feel like my lips "like they were going to sleep" and tingly. I went to the ER.
Information has been received from a physician concerning a "2-4" month old patient who was vaccinated with a 2 ml PO first dose of Rotateq. Subsequently the patient developed abdominal cramping after vaccination. Medical attention was sought. No labs were performed. Subsequently, the patient recovered. The patient will not received the rest of the series. There was no product quality complaint involved. Additional information has been requested. This is in follow-up to report (s) previously submitted on 4/13/2007.  Information has been received from a physician concerning a "2-4" month old patient who was vaccinated with a 2 ml PO first dose of ROTATEQ (lot # 655406/1114F).  Subsequently, on 10-DEC-2006 the patient developed abdominal cramping after vaccination.  The abdominal cramps lasted 1 day.  Subsequently, on 10-DEC-2006, the patient recovered.  Medical attention was sought.  No labs were performed.  The patient will not received the rest of the series.  There was no product quality complaint involved.  Additional information has been requested.
pt recv vax 7 2wk later pt exp urticaria that lasted 4 to 6 wk;pt recovery status not reported;MD office reported that pt moved to Denver, CO & did not respond to MD phone messages for f/u info;
This spontaneous report as received from a pharmacist refers to a 64 years old male patient. The patient was vaccinated with a dose of 0.65 ml ZOSTAVAX (lot # 671609/1165AA) subcutaneous on 28-APR-2012. No other co-suspects were reported. No concomitant medications were reported. Approximately on 05-MAY-2012 "one week later" the patient developed shingles. The patient sent a letter to the pharmacy's corporate office, and the pharmacist was notified "today" on 02-AUG-2012. The patient was fine now and shingles was resolved. Additional information has been requested.
Headache. Muscle aches. Fatigued. Red face?flushed - low grade fever.
Site: Pain at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Severe, Systemic: Nausea-Medium, Systemic: Shakiness-Medium, Systemic: Weakness-Severe, Additional Details: Patient presented about 10 min after vaccination as lightheaded and nauseous. Patient vomited one time. EMS was contacted, when they arrived the patient's BP was 90/60 and HR was 88 bmp. Parent of patient refused hospital transport after EMS gave all clear, and patient was able to talk, stand, etc on her own. Mother stated that patient was very anxious before and during the vaccine.
Initial and follow up information has been received from an RN and a practice manager concerning a female patient, aged between 35-50, who on 18-SEP-2007 was inadvertently vaccinated in the right deltoid with a dose of pneumococcal 23v polysaccharide vaccine, lot #655765/0061U; instead of the flu vaccine. On 18-SEP-2007, the flu vaccine was to be given to elementary school teachers and their spouses. Due to human error (not product confusion), pneumococcal 23v polysaccharide vaccine, lot #655765/0061, was brought to the school and administered instead of the flu vaccine. The patient developed symptoms similar to cellulitis. Her right arm, the inner aspect toward the elbow, was red, swollen, warm, and itchy. She was advised to take an antihistamine. As on 21-SEP-2007, she was "ok." The nurse also reported on additional patients who received pneumococcal 23v polysaccharide vaccine, lot #655765/0061U, instead of the flu vaccine; some of whom had adverse reactions. The practice manager stated "is anything wrong with this lot?" and a lot check was requested. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. Additional information has been requested.
pt became faint, rigid, sz lasting about 20-30 sec-fainted again; immed bolted upright & asked if had fallen asleep; event lasting under 2 mins;
Injection site reaction (red rash) that persisted for 2 months. About a week later there was a reaction on her leg very similar to shingles - neurpathic pain, with a tingling feeling before the blisters appeared, erupted, and scabbed over.
Giant Cell Arteritis. Pain at left temple, headaches .  Still treating with prednisone
Information has been received from a lawyer regarding a case in litigation concerning a male patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 01-DEC-2014, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 16-JUN-2016, the patient was treated by a physician for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Headache, Myalgia fatigue Narrative: Per nursing report: "Called to report took first dose Moderna vaccine yesterday [7/29]. C/o headache, fatigue and myalgia. Stated did not report to work today[7/30] due to not feeling well. "
she is in severe pain; She was feeling nauseous and throwing up; She was feeling nauseous and throwing up; This is a spontaneous report from a contactable consumer or other non hcp.   A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as UNKNOWN, SINGLE DOSE for covid-19 immunization. The patient medical history was not reported. The patient received the Pfizer shot (Covid vaccine) on Monday and Thursday night she started having severe migraine headaches and this morning she was feeling nauseous and throwing up and she still has the migraine headaches, she is in severe pain. Reporter wanted to report it and needed some advice what to do. The patient's concomitant medications were not reported. On an unspecified date the patient experienced she is in severe pain (migraine). On 27Mar2021 she was feeling nauseous and throwing up.  Therapeutic measures were taken as a result of she is in severe pain (migraine). She takes Advil migraine, it's the strongest cut down half of migraine headache because this is a symptom for maybe the Pfizer vaccine not supposed to do anything for the symptoms. The outcome of severe pain (migraine) was not recovered. The outcome of nauseous and throwing up was unknown.    No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Information has been received from a physician who is the mother of a pt who was vaccinated "several years ago" with a dose of varicella virus vaccine live. Subsequently, the pt "had a breakthrough case" with 150 lesions and "no fever".  It was noted that the child had to stay home from school. The physician also mentioned (WAES # 0312USA00828) who also was her child and (WAES # 0312USA01109) who experienced similar reactions. Additional information has been requested.
No additional AE reported; temperature excursion of 47.9 F for 47 min on 01-DEC-2022; This spontaneous report was received from a certified medical assistant (CMA) and referred to 2-month-old female patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 28-DEC-2022, the patient was vaccinated with first dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscular injection, lot #W006596, expiration date: 11-OCT-2024, administered intramuscularly for prophylaxis in left thigh (strength and dose was not provided), and with first dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, lot #1892784, expiration date: 03-DEC-2023, administered orally for prophylaxis (strength and dose was not provided).  The administered doses of the vaccine experienced a temperature excursion (product storage error) since 01-DEC-2022. The vaccine administered were stored at temperatures excursion of 47.9 Fahrenheit (storage in clinical practice) for 47 minutes. Digital data logger was involved. No additional adverse event was reported (no adverse event).  This was one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2301USA009088:
Patient states that starting 12/24/12 he developed severe pain in right arm as day progressed he lost function of right arm/hand. Patient went to ER. Doctor diagnosed him with "neuritis" resulting from flu vaccination. Rx prednisone, ketorolac, PERCOCET.
39 y/o with past medical history of Hypertension that presents with feeling weak, nervous and concerned for BP post vaccination. Patient states that this is the first vaccination in the two-dose series. Patient denies previous vaccination reaction. Patient states that the vaccination was received in the left arm. Patient placed in wheelchair and taken to the partitioned area with the NP and Paramedics. Patient initial vitals all within normal limits, 125/92 BP, 97 HR, 98 %RA, 12 Resp. Patient provided a bottle of water and monitored for 15 mins. Patient states that is feeling better and that feels that it was just nervousness. Patient vitals reassessed and normal, 127/85 BP, 98 HR, 99% RA, 12 Resp. Patient discharged in stable condition, ambulated without difficulty. NP encouraged patient to hydrate well since patient will be going back to work in an outdoor environment.
This spontaneous report as received from a health care worker refers to an unspecified number of patients of unknown age and gender. No concurrent conditions or medical history were reported. The reporter stated that since 16-JUN-2015, the patients were vaccinated with doses of ROTATEQ oral (Lot# K013861, expiration date 18-MAY-2016; Lot # K014826, expiration date 28-MAY2016) (doses and route were not specified), which were exposed to temperatures outside of the recommended range on 16-JUN-2015. No concomitant medications were reported. No adverse experience has been observed or reported. This is one of several reprots from the same source. Additional information has been requested.
patient awoke at around 9 am with a severe bloody nose. he used several tissues and had to cup his hand to catch all the blood. described having swallowed alot of blood before he sat up.
Head felt tight on Right side of head, difficulty remembering, shortness of breath, memory loss, headache.
Subcutaneous erythema, warm the edema in circumference4 cm diameter oval around injection site.
Severe headaches; Nausea; Fever up to 100.2; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Severe headaches), NAUSEA (Nausea) and PYREXIA (Fever up to 100.2) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, the patient experienced HEADACHE (Severe headaches), NAUSEA (Nausea) and PYREXIA (Fever up to 100.2). At the time of the report, HEADACHE (Severe headaches), NAUSEA (Nausea) and PYREXIA (Fever up to 100.2) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information included that patient took unspecified medications for nausea and headaches.
LYMPHADENOPATHY; LYMPHADENOPATHY. Information has been received from a registered nurse concerning a 24 year old male clerk who on 23-SEP-2003 had a hepatitis B surface antibody titer of <2.0. On 01-OCT-2003 the patient was vaccinated intramuscularly in the left deltoid with a second dose of hepatitis B virus vaccine rHBsAg (yeast) and on 05-NOV-2003 was vaccinated intramuscularly in the right deltoid with a third dose of hepatitis B virus vaccine rHBsAg (yeast) (lot # for 644394/0154N). On 03-OCT-2003, 48 hours post-vaccination, the patient "noticed" a left axillary adenopathy that was on-tender. It was also reported that the patient had a similar event after the third vaccination with right axillary adenopathy. The adenopathy has now resolved. It was also reported that "several years ago" the patient had received a first dose of hepatitis B virus vaccine rHBsAg (yeast)(manufacturer unknown) without problems. Unspecified medical attention was sought. There was no product quality complaint involved. No further information is expected.
Patient is a 28 year old G1P0 at 38 weeks & 1 days confirmed by ultrasound for an EDD of 2/1/22. She presented to L&D for IOL 2/2 vaginal bleeding, CTX, COVID positive, 38 week gestation. Patient reports feeling well, has no complaints.  Patient report uncomplicated pregnancy thus far. Denies headache, change in vision, loss of fluid, vaginal discharge, swelling, chest pain, shortness of breath, abdominal pain, nausea, vomiting, diarrhea, dysuria, fever/chills. She reports good fetal movement throughout pregnancy. Takes PNV. OB Hx: G1P0 uncomplicated pregnancy.  DISHCARGE HAS NOT BEEN UPLOADED AT THIS TIME.
Woke up 8/27/05 covered in hives, rec'd Dtap 8/23/05. No new food or any other cause for Hives. Rx: Benadryl, Orapred, child recovered.
30JAN redness 1" diameter, sore arm, aching bones, fever; 31JAN redness @ inject site, 2 1/2" diameter, very hot; 1FEB lump @ center; 3FEB site itching, lump still present;
flu vaccine was administered per pt request when they were here for daughter's appt. When documenting that the vaccine was administered, it had showed pt had rec'd flu vaccine a week prior.  Message sent to pcp as FYI and to advise if any reactions that pt should look for
lot number O70H21A, that has an expiration date of 7 Apr 2022, which was received between 8 Apr 2022 and 15 Dec 2022; no adverse event; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (lot number O70H21A, that has an expiration date of 7 Apr 2022, which was received between 8 Apr 2022 and 15 Dec 2022) and NO ADVERSE EVENT (no adverse event) in a 70-year-old male patient who received mRNA-1273 (Spikevax) (batch no. O70H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (lot number O70H21A, that has an expiration date of 7 Apr 2022, which was received between 8 Apr 2022 and 15 Dec 2022) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (lot number O70H21A, that has an expiration date of 7 Apr 2022, which was received between 8 Apr 2022 and 15 Dec 2022) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (lot number O70H21A, that has an expiration date of 7 Apr 2022, which was received between 8 Apr 2022 and 15 Dec 2022).  ID was reported as 80777027399. Person number was reported as 160626. Patient's age was reported as 70 Year 0 Month. No concomitant medications were reported. completion date was reported as 01-Aug-2022. The vaccine from the vial with lot number O70H21A was administered to the patient in between a period of 08-Apr-2022 to 15-Dec-2022. No treatment medications were reported.
p/vax pt devel inj site rxn of large area of swelling; redness & warmth
This spontaneous report was received from a other health professional refers to patients of unknown ages. On an unknown date the primary reporter reported that patients were vaccinated with PNEUMOVAX 23. Other suspect therapies included GARDASIL, M-M-R II, VAQTA, VARIVAX (Merck), ROTATEQ oral and RECOMBIVAX HB underwent temperature excursions. The healthcare worker reported that does were administered or how many patients. The healthcare worker stated that she will have someone call back with further information from the office that this occurred at. On an unknown date the patients experienced temperature excursions and no adverse effect. The outcome of temperature excursion and no adverse effect is unknown. The reporter considered temperature excursions to be not related to VAQTA, RECOMBIVAX HB, VARIVAX (Merck), GARDASIL, PNEUMOVAX 23 and ROTATEQ oral. Action taken with the therapy drugs were not provided. The reporter considered no adverse effect to be not related to PNEUMOVAX 23, VAQTA, VARIVAX (Merck), ROTATEQ oral, GARDASIL, and RECOMBIVAX HB. No further information was provided. Follow-up 09-Dec-2014: reported that the primary reporter is physician. The physician reported that since first week of Jun-2014, GARDASIL, VAQTA (adult formulation), and PNEUMVOAX 23 were improperly stored. Unknown number of doses were administered to unspecified patients. No adverse effects. No additional information was provided by this reporter. No additional information was provided by this reporter.
I received vaccine my wife started with pain the following week and then shingles 5 days later. She has worked in medical field for many years and never had shingles and has had contact with patients that have had them. As of today still having significant pain.
Had immediate soreness at injection site, no redness/rash/swelling/warmth. Has ongoing soreness/pain extending into shoulder joint along with decreased range of motion.
The morning after receiving the vaccines patient experienced fatigue, dizziness and described her condition as being sick/ill which continued for 7 days. Within several days her eczema/psoriasis began to flare severely causing her to visit her dermatologist on 10-17-2018 for treatment/abatement.