chrisvoncsefalvay/vaers-outcomes huggingface dataset:
entire multi-dose vial of vaccination/she was given up to 10 doses; a lot of arm pain; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team.  An 8-year-old female patient received BNT162b2 (BNT162B2), on 27May2022 as dose number unknown, single (Lot number: FL809) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset May2022, outcome "unknown", described as "a lot of arm pain"; OVERDOSE (non-serious) with onset 27May2022, outcome "unknown", described as "entire multi-dose vial of vaccination/she was given up to 10 doses".  Additional information: Question: On 28MAY2022 after hours VM left at 1:39PM EST: verbatim: Hi, my name is (name withheld), I am calling, I am not in the office today, apologize it is raining here. My phone number to call me back is (phone number withheld). I am calling because I have been notified by a patient that a local pharmacy inadvertently gave a child, an 8-year-old Female, an entire multi-dose vial of vaccination, rather than just one dose. They are not 100 percent sure how much she was given, they have just said that she was given up to 10 doses. So, um, if somebody could call me back and guide me on what I should tell this patient as far as, on if they have any information on suspected or reported effects. I would just appreciate any guidance that could be offered. Again, my name is (name withheld). I am a Nurse Practitioner, and my phone number is (phone number withheld). Thank you. Hi, I apologize, I am camping and in a rain storm. The pharmacy called the patient's parent this morning and said they gave the entire vial to the patient, but they did not indicate it was the wrong formulation. The patient's Father texted me a photo of the LOT# Pfizer FL809. If they have a low threshold, they may take the child to the Emergency Room. They did note that the child has a lot of arm pain. She received the dose yesterday and they didn't know it happened until the pharmacy called today. The caller is asking for guidance and what to tell the parents to expect. The caller would like to wait and check with the parents. They are understandably now vaccine hesitant and very upset. The caller is pretty sure the pharmacy will report. They better report. They will be filing the information that this happened. Caller added that having this information is helpful, if they end up going to the Emergency Room, they have something to bring with them.
Information has been received from a pharmacist concerning a male who on 04-SEP-2007 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck) instead of zoster vaccine live (Oka/Merck) (MSD). Reporter indicated it was due to staff error. No further information was provided. There was no product quality complaint involved. No further information is available.
This spontaneous case was reported by a consumer and describes the occurrence of PAIN (usual soreness) and ENERGY INCREASED (high levels of energy) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced ENERGY INCREASED (high levels of energy). On an unknown date, the patient experienced PAIN (usual soreness). At the time of the report, PAIN (usual soreness) and ENERGY INCREASED (high levels of energy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. Treatment information was not provided.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No concurrent conditions or medical history were provided. On 09-JUL-2014 (reported as today), the patient was vaccinated with an expired dose of ZOSTAVAX injection (lot # J003805, expiry date: 03-JUL-2014; dose, route of administration and indication unspecified). No concomitant medications were reported. No adverse effects were reported. Additional information has been requested.
Patient received PCV13 on 7/28/16 - Next day noted pain, redness and swelling of injection site >1cm knot noted at site. Redness spread to cover an area approx. 10cm x 6cm of upper arm. Area slightly warm to touch.
Injection given in the late morning, noted some redness and swelling of arm at the injection site.  That evening redness and swelling subsided but he developed LE weakness and soreness. He describes it feeling like he had just done a strenuous leg workout. No recent injuries or workouts. The following day he developed some pressure in his arms. LE pain is sometimes sharp, feels like his knees are buckling, and feels weak. Occasionally feels some paresthesias in fingers of R hand. Felt a little dizzy, took a decongestant and took his prescribed ativan and omeprazole and the dizziness subsided. Seen in ER on 11/22 and exam benign, labs including CBC metabolic panel, liver functions, CK normal, ESR mildly elevated at 28 Saw me (PCP) on 11/25 and reported For about 5 days after vaccine tingling from knees down, bottoms of feet feel on fire  And random nerve pain shooting off--like a quick shock --could be upper arms and hands. also R 2nd finger feels like a needle in it. Had a lot of fatigue slept 15 hours daily. Achey all over. Exam then showed normal reflexes, toes downgoing. Leg strength seemed intact but he felt it was not quite his normal strength. Repeat ESR normal at 8. He contacted me on 11/27 --not better-- I rx gabapentin for the neuropathic pain and prednisone 40 mg daily for 5 days for possible inflammation. on 12/11 he wrote me:  I am 85% better.  The nerve sensations (feet feeling fire, cold, wet, etc) happen in the morning mostly or when I have been sitting for an extended period of time.  I find my legs especially the Achilles are much more sensitive than before.  .
I received a Td vaccine and a Pneumoccoccal Conjuate vaccine at the same time (different arms). Approximately 20 minutes after receiving the vaccines I began to feel unwell. At that time I experienced an overall lathargic feeling and slight weakness. I left the facility and stopped to a grocery store. After just a few minutes the unwell feeling worsened and I began to feel an overall soreness. Once that feeling started I abandoned my shopping plan and left the store. I sat in my car for just a couple of minutes contemplating if I felt poorly enough to call for help. After a short rest I felt ok and that the adverse affects was wearing off. I then proceeded to drive home. While driving and having to be alert the lathargic feeling came back, but I still felt ok to drive and had only about 15 miles to go. Suddenly I became alert and found myself swerving towards the median of the interstate. I have no memory of nodding off or even drifting into another lane. I was able to correct my path. I was not in a location where I could have pulled offer, but I was back to feeling like I had control again. Then after a few more miles the exact same thing happened and I found myself swerving towards the median again. I regained alertness and planned to pull into a rest area about 500 feet away, however the rest area was completely closed off and due to road work, no shoulder was available to pull into. Now I am about 7 miles from home, and once again I regained alertness. In those 7 remaining miles I had 2 more incidents. Each time thinking I felt better than the one before and believing I was ok to continue on. Once home it took every effort to get inside. I staggered into the house and yelled for my husband who helped me go directly to bed. After a few minutes we discussed what happened. He was about to call an ambulance but I refused as I felt that if I just napped for a bit all would be well. I felt ok laying down and knew my husband would be checking so I was feeling safe and did fall asleep for about 6 hours. I was hungry so I did get up to eat and use the bathroom but other than that I was bed bound for two more days. I was unable to go to work until 8/10/23 and that was only for a partial day. The next day I was feeling back to normal with the exception of the arm where I had the Td vaccine. It was still hot, sore and visibly swollen, as the day went by my arm returned to normal.
Information has been received from a registered nurse concerning a 19 year old female with asthma, anxiety depression and no known drug reactions/allergies who on 21-Sep-2007 her second vaccination with Gardasil (Lot #658490/0802U).  Concomitant therapy included FLONASE and albuterol.  On 21-Sep-2007 the patient fainted after receiving her second dose of Gardasil.  The patient hit her head on the wall after fainting and was taken by ambulance to the emergency room.  Subsequently, the patient recovered.  It was noted that although the patient suffers from anxiety depression disorder she was not nervous at the time of the injection.  The patient received her third dose Gardasil on 25-Jan-2008 and did not faint afterward.  The registered nurse considered the patient fainted and hit her head on the wall to be other important medical events since the patient was taken by ambulance to the emergency room.  Additional information has been requested.
anaphylactic reaction; This is a spontaneous report from a Pfizer-sponsored program Pfizer RXPathways received by a contactable consumer(patient). A patient of unspecified age and gender received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization.  The patient medical history and concomitant medications were not reported.  The patient experienced anaphylactic reaction to the first dose of the vaccine on an unspecified date and went to the hospital with outcome of unknown.    Information on the Lot/Batch Number has been requested.
pt recv vax & had uncontrollable crying for 3 hr in 24 hr;
episode of limpness & unresponsive 3-4hrs p/shot; lasted 3-4 mins; was OK on arrival to office;
Itchiness; His muscles have tightened up; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itchiness) and MUSCLE TIGHTNESS (His muscles have tightened up) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included PARACETAMOL (TYLENOL) for an unknown indication.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Feb-2021, the patient experienced PRURITUS (Itchiness) and MUSCLE TIGHTNESS (His muscles have tightened up). At the time of the report, PRURITUS (Itchiness) and MUSCLE TIGHTNESS (His muscles have tightened up) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
When pt woke up on the day after vaccination she had a quarter-sized lump at injection site of RA. She also reported it to be hot/hard and a bumpy, itchy rash. The lump grew to the size of a baseball by 11/21. Pt told to take BENADRYL and contact MD if it got worse or did not improve.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. Information regarding medical history, concurrent conditions and concomitant medications was not provided. In 2016, the patient was inoculated with ZOSTAVAX at a pharmacy, as recommended for routine adult health maintenance and for the long-term prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster. Later in 2016, the patient was treated by a healthcare facility/unspecified healthcare professional for the onset of a vesicular rash, 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. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Redness, swelling, high fever, induration, pain -> cellulitis, seen in emergency room.
Rash, itching, treated by patient with Benadryl and hydrocortisone cream on day after immunization. Rash and itching improved on second day after immunization
Info has been received from an RN concerning a 30 year old female pt with no known drug allergies who in 1992 and 2002 was vaccinated with 2 doses of MMRII. at other facilities. There was no concomitant medication. On 4/26/05, titer was drawn and the client failed to seroconvert to measles only. The pt sought unspecified medical attention. There was no product quality complaint involved. Additional info has been requested.
About three hours after getting a vaccine, I had numbness in the anterior portion of my tongue on the left side. Facial muscles were numb on the left side for about six hours. 24 hours post vaccination, symptoms have resolved.
PATIENT HAS HIVES, PALENESS, WEAKNESS, DIZZINESS.  i TOOK PATIENT TO EMERG. ROOM ON 10-26-08.  sTEROID SHOT AND STEROIDS GIVEN.  TOOK PATIENT TO FAMILY DR ON 10-27-08 TOLD TO DOUBLE STEROIDS AND WAS GIVEN STEROID CREAM.  MY SON IS NO BETTER! HIVES ARE, BUT HE PASSED OUT AT SCHOOL TODAY 11-03-2008! oUR DR. WOULD NOT SEEM HIM DUE TO OUR NEW INSUR COVERAGE!  iM OUT RAGED AND WORRIED ABOUT MY SON!
Severe nausea Vomiting Upset stomach Arm soreness Severe tiredness but could not sleep due to other symptoms Tried ibuprofen and tylenol but could not keep down.  Vomited even when drinking just water.    Daughter is only 100 pounds. Have to question if someone at this weight range should be receiving a smaller dose, as she was ill with first dose also.  nausea and vomiting lasted through evening of 10/26/2021. Soreness and tiredness lasted through 10/27/2021 but was able to sleep once nausea and vomiting subsided.
Right arm - redness, swelling, hot to touch at injection site, size of a half dollar x3-4 days.
10x6 cm redness, induration, warm rxn lt arm, began swelling 11OCT91; c/o h/a 12OCT91 & chest pain 2-3cm from lt nipple 12OCT91; Pt continues to have h/a but denies CP;
Patient started experiencing chills, fever, and soreness at the vaccine site. Symptoms persisted for 12 hours. They resolved after 12 hours and patient does not have any side effects.
Patient described sudden: dizziness, vertigo, anxiety, trouble walking, and trouble speaking at the 20 minute mark after receiving vaccine. Patient had checked her self out of our clinic monitoring area at the 15 minute mark.
No appetite; Fever; Chills; Headache; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (No appetite), PYREXIA (Fever), CHILLS (Chills) and HEADACHE (Headache) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Disability (The patient is disabled and not able to get his card right now.).    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, the patient experienced DECREASED APPETITE (No appetite), PYREXIA (Fever), CHILLS (Chills) and HEADACHE (Headache). At the time of the report, DECREASED APPETITE (No appetite), PYREXIA (Fever), CHILLS (Chills) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product details was not provided by the reporter. Treatment information was not provided. Patient declined to provide an email address.   Most recent FOLLOW-UP information incorporated above includes: On 13-Jul-2021: TCR received on 13-JUL-2021 contains No New information
This case was reported by a consumer via call center representative and described the occurrence of generalized muscle aches in a 59-year-old male patient who received SHINGRIX for prophylaxis. Concomitant products included SHINGRIX. On 28th August 2018, the patient received the 2nd dose of SHINGRIX .5 ml. On 28th August 2018, less than a day after receiving SHINGRIX, the patient experienced generalized muscle aches. On an unknown date, the outcome of the generalized muscle aches was not recovered/not resolved. It was unknown if the reporter considered the generalized muscle aches to be related to SHINGRIX. Additional information was reported as follows: This case was reported by the patient's wife. In June 2018, the patient received the 1st dose of SHINGRIX without any adverse events. The patient experienced muscle pain after the 2nd dose of SHINGRIX. This case was linked to case US2018157105, reported by the same patient.
Pain, redness and swelling at the injection site. Muscle ache throughout upper back torso and back of neck. Felt like I had flu symptoms with headache, dizziness, lethargy, chills and low fever. Such symptoms disappeared within 3 days. However, the injection site remained swollen, itchy, red and discolored (similar to a bruise). The redness and discoloration were slightly larger than the size of a silver dollar and lasted 7 days. Thereafter, everything disappeared. I took ADVIL and rested during this time in response to the reaction.
get second booster shot and it made her sick; she was in bed; soreness in injection site; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (get second booster shot and it made her sick), BEDRIDDEN (she was in bed) and VACCINATION SITE PAIN (soreness in injection site) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product OBETICHOLIC ACID (OCALIVA) tablet for Primary biliary cholangitis.    Concurrent medical conditions included Primary biliary cholangitis, Pruritus, Nausea (Since 2013) since 2013 and Headache (Since 2013) since 2013.   On 23-Dec-2016, the patient OBETICHOLIC ACID (OCALIVA) (Oral) dosage was changed to 5 milligram once a day. In 2021, OBETICHOLIC ACID (OCALIVA) (Oral) dosage was changed to 5 milligram once a day. On 25-Jun-2021, OBETICHOLIC ACID (OCALIVA) (Oral) dosage was changed to 5 milligram three times per week. On an unknown date, the patient received fifth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and OBETICHOLIC ACID (OCALIVA) (Oral) 5 milligram three times per week. On an unknown date, OBETICHOLIC ACID (OCALIVA) (Oral) dosage was changed to 5 milligram once a day, OBETICHOLIC ACID (OCALIVA) (Oral) dosage was changed to 5 milligram three times per week and OBETICHOLIC ACID (OCALIVA) (Oral) dosage was changed to 5 milligram. On 19-Apr-2022, the patient experienced ILLNESS (get second booster shot and it made her sick), BEDRIDDEN (she was in bed) and VACCINATION SITE PAIN (soreness in injection site). At the time of the report, ILLNESS (get second booster shot and it made her sick), BEDRIDDEN (she was in bed) and VACCINATION SITE PAIN (soreness in injection site) outcome was unknown.            Concomitant medication information was not provided by the reporter.  The causal relation of the events with Ocaliva was not reported.  Treatment information was not provided by the reporter.
Within 10 mins of vaccines pt stated vomiting and gagging, followed by diarrhea. Pt lethargic and skin color very pale with eyes rolling-11:49 IM given; 11:59 symptoms began, call placed to DR., instructed to send to ER 12:03 arrives. 12:20 mom refused ambulance 12:48 pt better playing; left going to Dr's office.
her arm itching off; she has the big red rash on her arm that is hot to touch it is not hurting her but it is hot to touch and it is about the size of golf ball, perfectly circular; she has the big red rash on her arm that is hot to touch it is not hurting her but it is hot to touch and it is about the size of golf ball, perfectly circular; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 9-year-old female patient received bnt162b2 (BNT162B2), administration date 23Nov2021 (Lot number: FK5618) at the age of 9 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Blood iron decreased" (unspecified if ongoing), notes: Verbatim: Iron low. There were no concomitant medications. The following information was reported: PRURITUS (non-serious) with onset 02Dec2021, outcome "unknown", described as "her arm itching off"; RASH ERYTHEMATOUS (non-serious), FEELING HOT (non-serious) all with onset 02Dec2021, outcome "unknown" and all described as "she has the big red rash on her arm that is hot to touch it is not hurting her but it is hot to touch and it is about the size of golf ball, perfectly circular". Therapeutic measures were not taken as a result of pruritus, rash erythematous, feeling hot.  Additional Information: The reporting parent stated that her daughter was nine. She actually got the Pfizer Vaccine her first dose 9 days ago and today she started complaining of her arm itching off and now she has the big red rash on her arm that is hot to touch it is not hurting her but it is hot to touch and it is about the size of golf ball, perfectly circular and I was trying to see if that was normal". Reporter stated, "Can you tell me that, it will can you please let me know I am guessing it's COVID arm, is that normal for her age group". Prior vaccination (within 4 weeks) was none. Vaccination facility was at Doctor's office. No lab test.  No follow-up attempts are possible. No further information is expected.
Chills which happened daily for over a month and occurs regularly even now. Leg pain and difficulty walking started about 10 days later and continues today. It even wakes me up at night. Tiredness and fatigue also continues.  On July 9 ,2021 heart doctor visit next thing I know I.m going to ER then transferred for a pacemaker.  The above chills, leg pain, fatigue continues as of today 9-17-2021
Headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042L20A and 022M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history). Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) and FENTANYL for an unknown indication.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Jan-2021, the patient experienced HEADACHE (Headache). On 26-Jan-2021, HEADACHE (Headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-051600 (Patient Link).
Pt received Men B on 7/27/18- (L) deltoid. She describes 1 week H/O (L) arm numbness, weakness, H/A following IMS.
Almost immediately after injection patient has horrible taste in mouth and be came violently sick patient was throwing up and nose started to bleed.
Fever of 99.9 with nausea sensations loose bowels starting Saturday morning.  temp rise starting late afternoon continuing through most of the night.  Waking up with a strange bellyache that lasted into the afternoon.  Didn't feel well until mid morning Monday the 18th.
fever up to 102.3, severe body aches and chills for about 24 hours