chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician concerning a male pt who on 12/24/2001 was vaccinated with one dose of varicella virus vaccine live. On 12/31/2001, one week post-vaccination, the pt developed lesions and temperature, as reported by his parents. The pt sought unspecified medical attention. The physician requested a lot check on the lot because there were "more phone calls than ever before." The records of testing prior to release of this lot have been checked by CMP Compliance and found to be satisfactory. This lot complies with the standard of the Center for Biologics Evaluation and Research and was released. Follow-up info on 03/07/2002, from a physician noted there were no more adverse events to report other than those that were previously reported. The physician stated that the reason she used the phrase "more calls than ever," was because she has been in practice for a number of years, and always gave pt/parents standard info on the benefits/risks of the vaccine before its administration, and also instructed them to call the office if the child experienced any problems post-vaccination. The physician reported that in her years of practice, it had been her experience that parents very rarely call their office to report a post-vaccination reaction. It was very unusual for their office to receive as many calls as they did in January 2002, including this pt and other pts who were vaccinated and experienced similar events (WAES0202USA00428, 0202USA00429, 0202USA00430, 0202USA00431, and 0202USA00432). The physician also thought it was unusual that several of the adverse events seemed to be occurring at day 10 post-vaccination. It was noted that there were no additional cases reported and the increase in calls was just n the month of January 2002. They did not experience any unusual volume of calls in February or thus far in March 2002. Additional info has been requested.
4 hours after receiving vaccine, I was replacing a door handle, and thought I had moved my arm in such a way that it had subluxed at the GH joint. The acute, immediate pain in the joint and inability to move my shoulder were surprising. It took me a few minutes to realize this was likely a reaction to the shot. The joint pain migrated to my elbow, wrist, hand, and left side of my neck, and those joints were all cracking for about 2 days. My left shoulder is still experiencing discomfort and cracking frequently when I move that arm.
At 4:15  pt c/o diziness, right side pain shooting from neck down to back/scapular. Burning sensation  and hotness at needle site and weakness. Cold ice pack was applied. Vitals included 116/76, 76, 98%RA. Pt A&O x4. Rr=16. After 40 mins of observation  symptoms did not subside. 911/EMT arrived at 1643 and pt. Taken to ER for further mornitoring.
Pt recvd 3 doses of Engerix-B vax & exp no adverse rxn; HBSAB was neg p/completing the series; pt recvd booster dose of Engerix-B 13NOV91 & titer not drawn again as of 10FEB92;
Six days after injection of vaccine, the injection site became very inflamed again, red, hot to the touch, and extremely itchy. A large knot developed under the skin on my left bicep, and the redness continues to spread at this time. Today is the third day since this reaction started, day 9 post-vaccine.
Initial information has been received from a physician and follow up information received from a health professional concerning a 17 year old female student patient with no known drug allergies, and no previous medical history, who on 31-JAN-2008 at 4:30 PM, was vaccinated IM in the left arm with the first dose of Gardasil (lot# 659439/1267U). Concomitant therapy included YASMIN. Subsequently the patient experienced headache, dizziness, pruritus, fever, fingers tingling on left hand and fever blisters on her lips and inside her mouth. Emergency room medical attention was sought. The patient's outcome is unknown. No product quality complaint was involved. Additional information has been requested.
This spontaneous report was received from a medical assistant refers to a patient of unknown age and sex who on 02-JUN-2010 and 08-NOV-2012, was vaccinated intramuscularly with the first and second dose, respectively, of GARDASIL (dose and lot Number Not reported). No other co-suspects were reported. No concomitant medications were reported. No adverse effect reported. Patient's outcome was unknown. Additional information has been requested.
Menstrual spotting. No heavy bleeding. Irregular spotting for about a week following the vaccination
Patient was in the office and agreed to have Flu shot and Meningococcal. When preparing the vaccines, HPV was drawn and administered instead of Meningococcal. After realizing the error, the provider and lead staff were advised. Patient's father was advised of error. He was advised she may have pain around injection site, like any other vaccine but shouldn't have any side effects. He verbalized understanding. Also advised that she can come into the office to get correct vaccine in 30 days.
Following both of my Moderna vaccines, I developed a large rash on my arm. Following the first vaccine, the rash developed 8 days later. The rash developed the next day after my second vaccine and I became very ill with aches, fever, and intense fatigue. I was not concerned following these reactions as many people   I knew had similar responses. However, in April I went to an appointment to have routine bloodwork done and my results came back with low TSH. Follow up bloodwork revealed an abnormal thyroid panel and I?ve since been diagnosed with hyperthyroidism and possibly Graves Disease. My resting heart rate increased immediately following vaccination and has yet to return to my resting rate pre-inoculation. I believe that the vaccine was likely the catalyst for the thyroid issues I?m currently experiencing 5 months after my last vaccination.
Patient has Bell's palsy. The right side of his face is affected. He was originally seen in the ER and is going to a neurologist at Hospital tomorrow (07/21/17). He was given prescriptions for prednisone and acyclovir at the ER.
Shoulder injury: right arm rotation pain continuing to date; right deltoid contraction pain continuing to date; sensitivity at injection point continuing to date.
10/14/05 - Received vaccine at approx. 1:30pm.  By that evening, c/o soreness in left arm. 10/15/05 - at approx. 1:30pm - c/o cold chills, fever 101F, achy bones, left upper arm swollen and red/ hot to touch.   10/16/05 - Continued with c/o's from previous day and also c/o severe bone aches in arms and legs.   10/16/05 - Was seen in Emergency Room in the evening.  Diagnosed with cellulitis in left arm and treated with Levaquin by mouth.  Left arm was swollen to the size of an "orange", painful to move and hot to touch.  10/17/05 - Was seen by her primary physician at approx. 3pm.  Dr diagnosed her with a severe reaction to pneumonia shot - Dr did not diagnose her with cellulitis.  She was continued on Levaquin and also given Palgic and Ibuprofen. 10/18/05 - Swelling at injection site now size of a dime with redness.  Continues to c/o soreness and body aches.   Did visit ER and Dr's office.  Is missing second day of work today.
15 minutes after receiving varivax, patient c/o abd pain, nausea.  His mother noted that  his lips were starting to swell.  He was brought back into an exam room where he started vomitting.  He had a secure airway, no wheezing, no other hives, only swelling of his lips.  RR 12, HR 116, pulse ox 97-99% on room air.  Before he started vomitting we tried to administer p.o. Benedryl.  After his emesis we administered IM EpiPen Jr.  He stopped throwing up, got drowsy, but breathing remained unlabored, no wheezing, tachycardia resolved within 5-10 minutes and he did not require oxygen or albuterol.  He was observed for 45 minutes and maintained normal RR, HR 60's, oxyegen saturation 99-100% on room air, decreased lip swelling.  He was discharged home with instructions to give p.o. benadryl Q6 hours and to call or return if his symptoms returned or worsened.
On 04-25-2021 I started to bleed and spotting vaginally.  My water broke and I went into labor. I was admitted to the hospital on 04-27-2021.  I was in the hospital for one week. I had a covid-19 injection 04-26-2021 at 28 weeks. At the moment I am on bed rest up till my 36 weeks.
Information has been received from a healthcare worker referring to 2 unspecified patients of unknown age and gender. On 24-AUG-2015 the patients were inadvertently vaccinated subcutaneously with doses of MMR II injection which expired on 23-AUG-2015. No adverse effects reported. Additional information has been requested.
This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). A 48 year-old female patient received bnt162b2 (BNT162B2), administration date 01Mar2021 11:15 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CHILLS (non-serious) with onset Mar2021, outcome "unknown", described as "uncontrollable chills"; HEADACHE (non-serious) with onset Mar2021, outcome "unknown", described as "woke up with a headache"; HYPERSOMNIA (non-serious), PAIN (non-serious) all with onset Mar2021, outcome "unknown" and all described as "slept the whole day with body aches"; DECREASED APPETITE (non-serious) with onset Mar2021, outcome "unknown", described as "no appetite". Therapeutic measures were taken as a result of headache.Additional information: It was reported that, she woke up at 4 AM with uncontrollable chills and was up for awhile. She fell back asleep but woke up with a headache. Therapeutic measures were taken for headache with Tylenol but she slept the whole day with body aches and no appetite. No follow up attempts are possible. Information about Lot/batch number cannot be obtained.
A 71 year old female who has a past medical history significant for asthma, diabetes, hypertension, obesity, and diabetic neuropathy who presented to ED with worsening SOB secondary to COVID19. Patient states she was diagnosed with COVID-19 5 days ago. She had been experiencing shortness of breath that continually got worse.  Patient states that she became concerned so she came to the ED. In the ED she was found to have O2 sats in the 80s. She improved on 2-3L O2. She was afebrile with stable WBC. Labs showed procal 0.84, CRP 329.5, Ferritin 764, Na 133. Her chest xray showed patchy airspace opacities bilaterally in the mid lung zones, greater than than left.
This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and unknown gender. The patient pertinent medical history was not reported. On 25-NOV-2014, the patient was vaccinated with ZOSTAVAX (dose strength and route was not reported) (lot # J008433 and expiry date: 11-OCT-2014) which was improperly stored. Primary reporter was reporting excursion of 6 F since 01-JUN-2013 (confirmed date) affecting ZOSTAVAX, nurse also reported that products were not stored in an overall average support range of -58 degree F and 5 degree F. No adverse effects reported. No product quality complaint (PQC) was reported for ZOSTAVAX. This is one of the several reports from the same reporter. Additional information has been requested.
Multiple adverse side effects 24 hours post injection: soreness, swelling, hardness at injection site; neck and shoulder muscle pain; extreme tiredness and weakness; headache; upset stomach; diarrhea; belly pain; gas (burping and flatulence; lasted three full days with several days of recovery
Information has been received from an office manager concerning an 18 year old female patient with a history of twin birth who on 18-MAY-2010 was vaccinated with a fourth dose of RECOMBIVAX HB (lot number not available). The office manager reported that after the patient was vaccinated with the three doses of RECOMBIVAX HB, all blood work (hepatitis B surface antibody) came back negative (lab was 7), "not immune", requiring a fourth dose of RECOMBIVAX HB. The patient did not develop hepatitis B. No other adverse events were reported. At the time of the report the patient had not had follow up laboratories. The patient's outcome was unknown. It was unspecified if the patient sought medical attention. Follow-up information was received from the office manager who reported that the non-smoker female patient on 29-SEP-1992, was vaccinated with the first dose of RECOMBIVAX HB (lot number not available). On 18-DEC-1992, the patient received the second dose of RECOMBIVAX HB (lot number not available) and on 24-JUL-1993; the patient received the third dose of RECOMBIVAX HB (lot number not available). On 08-MAY-2010 an anti-HBs titer was performed which result was 7. The patient did not have immunity to hepatitis B virus at that moment. On the same day, a varicella zoster virus AB (IGG) was done which result was 2.89 (positive). On 18-MAY-2010, the patient received a forth dose of RECOMBIVAX HB (lot # AHBVB772CA). On 15-JUL-2010, an hepatitis B surface antibody test was performed which result was more than 1000. The patient had now immunity to hepatitis B virus. No adverse events were reported. It was unknown if the patient had any illness at the time of vaccination. This is one of several reports received from the same source. No further information is available.
a little bit of a sore arm/It was worse with the first injection.; a little bit of a sore arm/It was worse with the first injection.; This is a spontaneous report from a contactable consumer or other non-health care professional. Consumer reported for her husband. A 67-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection; Lot Number: EK3750) via an unspecified route of administration on an unspecified date (at the age of 67-yeras-old) as 1st dose, single for COVID-19 immunization at hospital. Medical history included and concomitant medications were reported as none. The second dose Lot number was reported was EJ1686. On an unspecified date, the patient experienced a little bit of a sore arm and it was worse with the first injection. He did not have a fever or anything. Investigation Assessment was reported as No. The outcome of the event sore arm was not recovered, and the outcome of "it was worse with the first injection" was unknown.  Follow-up attempts are completed. No further information is expected.
Covid-19; Muscle Pain; A report was received from a healthcare facility staff member concerning 53 year old female patient who was participating in the mRNA-1273 Emergency Use Program and experienced muscle pain and positive COVID-19 test.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 28 Dec 2020 prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot: 011-J20A) intramuscularly in the right deltoid for prophylaxis of COVID-19 infection.   On 29 Dec 2020, patient developed muscle pain and received a positive COVID-19 test.   No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events, muscle pain and positive COVID-19 test, were not reported  The reporter did not provide an assessment for the events.; Reporter's Comments: Based on the natural history of COVID-19, and the established information about the mRNA-1273 vaccine, a causal association between the event of tested positive for COVID and the product use is assessed as unlikely.  Based on the information provided, event most likely pre-existed vaccine administration.  The event of myalgia is consistent with the known safety profile of mRNA-1273 vaccine,  hence a causal relationship with the events cannot be excluded.
Typical pain at injection site within a few hours, but about 12 hours after injection I had near fainting, nausea, severe shaking/chills, headache. Developed a fever about an hour later. In the morning I felt much better, but still weak, queasy and head-achy. The second morning (about 48 hours after the injection) I was back to nearly normal.
pain underneath her arm; swelling underneath her arm; This spontaneous case was reported by a consumer and describes the occurrence of AXILLARY PAIN (pain underneath her arm) and LYMPHADENOPATHY (swelling underneath her arm) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, the patient experienced AXILLARY PAIN (pain underneath her arm) and LYMPHADENOPATHY (swelling underneath her arm). At the time of the report, AXILLARY PAIN (pain underneath her arm) and LYMPHADENOPATHY (swelling underneath her arm) outcome was unknown. Not Provided          No concomitant medications were reported.  No treatment information was reported.
Information has been received from a physician concerning a  patient (age and gender unknown) who on 19-FEB-2007 was vaccinated with Gardasil (Lot number 654540/0800F). on 19-FEB-2007 the patient the received vaccine in the bottom. No further information is available.
Extreme swelling in lymph node in arm pit; This is a spontaneous report from a contactable consumer (patient). A 42-years-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: Unknown), via an unspecified route on 24Jun2021 at 16:00 (at the age of 42-years) as dose 2, single for covid-19 immunisation. The patient medical history was not reported. The patient concomitant medications included Birth control unspecified medications in two weeks. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: Unknown), via an unspecified route on 03Jun2021 at 04:15 (at the age of 42-years) as dose 1, single for covid-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 26Jun2021 at 02:00, the patient experienced extreme swelling in lymph node in arm pit. The patient did not receive treatment for event. The outcome of the event was unknown.
severe headache, stomach ache with nausea x26 days, dizzinessx7days, uncontrollable cryingx4 days, anger x1 day
Mom noticed 7 clear vesicular lesions on left arm and shoulder on 9-07-07.  Afebrile - To Clinic - was seen by FNP - DX - Varicella post vaccination lesions crusted by today 9-12-07
Admission for chest pain that occurred 24hrs after vaccination and worsened. Elevated troponins with normal EKG and ECHO consistent with myocarditis.
moderna vaccine EUA within 5 minutes of receiving vaccine, had elevated heart rate to 140-150s, lightheadedness, chest burning, tingling in legs. Was taken to ER immediately and given IV steroids, IV Benadryl for severe allergic reaction.
Severe muscle pain (excruciating pain that went down my arm) Difficult to exercise due to the pain Chest pain (tightness in my upper chest & back) Shortness of breath and I get out of breath easily
patient received dose of pfzier covid vaccine and within 5 minutes started shaking from head to toe.  Ambulance was called.  Vitals were checked by EMT and patient sign off to go home with spouse
Burning Muscle Pain and Fever that was alleviated by Ibuprofen.  It happened the next day after immunization was given.  On 02/21/20, patient stated that pain felt better and no longer needed Ibuprofen
She was in her normal state of health and received high dose flu shot 10/12/20 around noon. At 5:30 AM 10/13/20, she woke up experiencing dizziness/vertigo, nausea, lightheadedness, and unsteady gait. She fell upon trying to get up. Her BP at this time was 149/60,  fasting blood glucose 163.  She called EMS and was brought to the ER as a stroke activation. Work as below.
Client presented at the vaccination site on 12.15.21. Client reported she received first dose Moderna COVID vaccine on 11/16/21. She reported with first dose Moderna COVID vaccine, the next day she had a very painful muscle ache on her left arm 10/10 on a pain scale of 10 on 11/17/21 then it was a 4/10 or 5/10 daily on a pain scale of 10, where she received her injection which lasted for three weeks. She denied rash or redness on the injection site. Client reported she took Ibuprofen 400 mg twice only on 11/17/21 but didn?t take Ibuprofen after 11/17/21. Client denied any chronic illnesses or any known allergies. She stated she didn?t follow-up with her PCP. She reported the injection side muscle ache of the left arm got better last week because she didn?t use her left arm that much. She reported no other symptoms. Client is requesting to get her second dose Moderna COVID vaccine on the same left arm because she stated she needs to use her right arm in case she gets the same painful muscle ache again on her left arm. PHN submitted a medical consult via text message to clinical project coordinator, requesting to proceed with the second dose of Moderna COVID vaccine. Per the doctor, approval to proceed with the second dose of Moderna COVID vaccine was obtained from medical consult team via text message from clinical project coordinator. Client received the second dose of Moderna COVID vaccine, LOT#: 069H21A on 01/08/22 at 1741 by RN. The client did not report any symptoms during the 30-minute observation period. PHN educated client on possible adverse reactions and when to seek EMS. Client verbalized understanding. Client left vaccination site at 1811 unassisted and with a steady gait.
Vaccine that was left at room temperature following punctuation for 26 hours; Vaccine that was left at room temperature following punctuation for 26 hours; Was dosed with 100ug for a booster instead of 50ug; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine that was left at room temperature following punctuation for 26 hours), ACCIDENTAL OVERDOSE (Was dosed with 100ug for a booster instead of 50ug) and PRODUCT STORAGE ERROR (Vaccine that was left at room temperature following punctuation for 26 hours) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 100 microgram. On 01-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine that was left at room temperature following punctuation for 26 hours) and ACCIDENTAL OVERDOSE (Was dosed with 100ug for a booster instead of 50ug). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine that was left at room temperature following punctuation for 26 hours). On 01-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine that was left at room temperature following punctuation for 26 hours), ACCIDENTAL OVERDOSE (Was dosed with 100ug for a booster instead of 50ug) and PRODUCT STORAGE ERROR (Vaccine that was left at room temperature following punctuation for 26 hours) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.
This spontaneous report was received from a medical assistant concerning to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant therapies, drug reactions or allergies were not reported. On 20-NOV-2015, the patient was vaccinated with improperly stored GARDASIL, lot # K011562, expiration date 08-APR-2017, (dose, dose number, route and anatomical location were unspecified). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.