chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This was 2nd dose of Moderna COVID 19 vaccine, patient didn't get any reaction after 1st dose. Patient was very conscious and in a good shape after 2nd dose too. However, while patient was under observation after the second dose almost 7 min. after the dose, pt started to fall from their chair to the floor while they were conscious as they put their hands front of them to touch the floor first. I stepped quickly on the floor to check the pt, cleared the air pathways, took their mask out, put them on their side, supported their head and was watching their vitals and called 911. Patient had a good pulse and breathing, they were conscious but their were closing their eye 1st for 2-3 minutes after falling on the floor. Then they opened their eyes and were moving their head to answer my question and check. Paramedic came within 5-7 minutes of the call while patient was in a better shape and we learned from the patient and the patient's son that pt didn't take any food since the day before the vaccine. Paramedic did their check on the pt and asked to take the pt with them to do more check, however pt said they feel far better and didn't want to go with the paramedic.
This spontaneous report was received from a physician refers to a patient of age 5 (unspecified units) (unknown gender). No pertinent medical history was reported. On 29-SEP-2014, the patient was vaccinated with (Oka/Merck) VARIVAX (lot # K002920 and expiration dates was 26-FEB-2016) dose 0.5 m, subcutaneous injection. Concomitant medications was not reported. The physician reported that temperature excursions beginning 11-AUG-2014, with worst case exposure to -3.9C for 110 hours affecting (Oka/Merck) VARIVAX with lot # K02920 and expiration date 26-FEB-2016. Excursion supported for use within 3 months. No adverse effects reported. Patient did not sought medical attention. No Product Quality Complaint (PQC) was involved. This is one of the several patients from the same source. Additional information has been requested.
Patient report that she was a bit "dizzy" and loopy. I told her that her symptoms were a bit worrisome. She presented with no other signs & symptoms of anaphylaxis. I told her if any symptoms (written on the EUA were present) she needed to go to ER ASAP.  She said her dad was driving her home, and she would be family all night.     I spoke to her again and she said she's feeling better. She was lightheaded  & had a headache  for 3 days.
I was leaving work and all of a sudden got very nauseous. I went home and pushed fluids and tried getting sleep. I kept vomiting due to the nausea. I was unable to work the next day. I also as still nauseous and I felt like I was going to pass out. I went to the urgent care and was tested for COVID which I was negative for. I was told to keep drinking fluids and rest. I spent 4 days and 3 nights in bed which is very unusual for me. I went into work on Sunday and have been feeling fine ever since.
Morning after receipt of vaccine a red, warm area 51 mm wide by 40 mm high area developed at injection site. No systemic reaction.
headaches; aches and pains; This case was reported by a nurse and described the occurrence of headache in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st September 2021, the patient received the 1st dose of Shingrix. In September 2021, less than a week after receiving Shingrix, the patient experienced headache and pain. On an unknown date, the outcome of the headache and pain were recovered/resolved.   The reporter considered the headache and pain to be related to Shingrix.  Additional details were provided are as follows: The case was reported by Nurse for himself/herself. The age at vaccination was not reported. The reporter received 1st dose of Shingrix 2 days ago and oh boy he/she got all the side effects that was expected and feeling better after a day of headaches and aches and pains but he/she know that it was worth that. The reporter stated as a nurse he/she had taken care of a few. The follow up could not be possible as no contact details were available.
really bad reaction; couldn't lift it; flu like symptoms; couldn't get out of bed; arm was so sore/ leg pains; aches; general fatigue; still have nausea; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (really bad reaction), MOVEMENT DISORDER (couldn't lift it), INFLUENZA LIKE ILLNESS (flu like symptoms), BEDRIDDEN (couldn't get out of bed) and PAIN IN EXTREMITY (arm was so sore/ leg pains) in an adult female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 11-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (really bad reaction), MOVEMENT DISORDER (couldn't lift it), INFLUENZA LIKE ILLNESS (flu like symptoms), BEDRIDDEN (couldn't get out of bed), PAIN IN EXTREMITY (arm was so sore/ leg pains), MYALGIA (aches), FATIGUE (general fatigue) and NAUSEA (still have nausea). The patient was treated with PARACETAMOL (TYLENOL) for Adverse reaction, at an unspecified dose and frequency. At the time of the report, IMMUNISATION REACTION (really bad reaction), MOVEMENT DISORDER (couldn't lift it), INFLUENZA LIKE ILLNESS (flu like symptoms), BEDRIDDEN (couldn't get out of bed), PAIN IN EXTREMITY (arm was so sore/ leg pains) and FATIGUE (general fatigue) outcome was unknown, MYALGIA (aches) was resolving and NAUSEA (still have nausea) had not resolved.            The patient had all Moderna vaccines and later had one bivalent vaccine two weeks ago , on 11-Oct-2022. The adverse reactions made the patient paused on the decision whether or not to get another vaccination.  The patient was on some medication before getting the vaccine but nothing that should interfere the vaccination. The concomitant  medication was not reported.
Son called stating his Mother started feeling terrible today.  Symptoms: Achiness, HA, fever, chills, shakes, nausea and stiff neck.
Patient said she was feeling dizzy, vision was blurry,  sweeting.  Was able to breath, asked for water which was given to her. She had some rash on the face, provided diphenhydramine liquid 50mg.  She was feeling feverish, took tylenol.
pt recvd vax 1SEP93  on 2SEP93 pt had a sz, t101; pt had been on ATB for OM on 1SEP93 pt was symptomtic; sepsis work up done; pt crabby; poss febrile sz;
About a month after the vaccine I developed severe pain in the shoulder joint of the arm just above where the vaccine was administered.  This pain made it difficult to move my arm and acted like a fractured bone or torn tendon.  However, X-rays revealed no physical damage.  That pain remained severe for months and has only recently declined.
Head ache evening of vaccination. Lips numb up to nose on 1/6/2021,and intermittently on 1/7/2021. Severe head ache 1/6/2021 with nausea. Continued moderate to severe headache with intermittent nausea. Mild nasal congestion and sneezing.
This spontaneous report as received from a registered nurse refers to a 2-month-old patient. The patient's medical history was not reported. On 11-JUL-2016, the patient was vaccinated with an improperly stored first dose of ROTATEQ lot # M014544, expiration date reported as 27-NOV-2017 (dose was not reported), orally. On the same day, the patient was vaccinated with a dose of PREVNAR 13 and a dose of ACTHIB. On 21-JUL-2016, the patient was inadvertently vaccinated with an improperly stored second dose of ROTATEQ lot # M014544, expiration date reported as 27-NOV-2017 (dose was not reported), orally. On the same day, the patient was vaccinated with a second dose of PREVNAR 13 and a second dose of ACTHIB. No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
No adverse effects reported.; an unspecified number of patients received improperly stored dose of RECOMBIVAX, GARDASIL 9, MMRII, or PROQUAD; The report was first received from a practice manager on 07-SEP-2018, and it was recognized as non-valid because report did not obtain any patient identify.  Follow-up information has been received from the practice manager on 18-SEP-2018.  This spontaneous report refers to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided.       On 23-APR-2018, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (recombinant Human albumin) (strength and route were unknown) (lot#  N020620 and expiration date 22-JAN-2019) for prophylaxis (Incorrect product storage). The sterile diluent (MERCK STERILE DILUENT) was properly stored. No adverse event was reported.  The excursion temperature on 22-SEP-2017, 17-OCT-2017, 06-DEC-2017, 07-DEC-2017, 30-JAN-2018, 23-FEB-2018, 18-MAY-2018, 05-JUL-2018, 15-AUG-2018 was 6 degree Celsius for maximize 8.75 hours. The excursion temperature on 02-MAR-2018, 27-AUG-2018 was 7 degree Celsius for maximize 8.75 hours. The excursion temperature on 07-DEC-2017 was 8 degree Celsius for maximize 15 hours. The call was not because of data logger.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1809USA003709: US-009507513-1810USA001951: US-009507513-1810USA001952: US-009507513-1810USA001953: US-009507513-1810USA001954: US-009507513-1810USA001955: US-009507513-1810USA001956: US-009507513-1810USA001957: US-009507513-1810USA001959:
About one week after the vaccine, the site of injection began to itch.  The site is a bit red, circular and I can see a point in the middle, presumably from the point of injection.  My husband experienced the same thing, but it took a week AFTER the injection to appear.
had some back pain/ back pain before the booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A male patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BACK PAIN (non-serious), outcome "unknown", described as "had some back pain/ back pain before the booster". Therapeutic measures were not taken as a result of back pain.  Additional information: Patient also had another question that he had booster on Wednesday and before he had the vaccine, he had some back pain and did not want to take any ibuprofen or anything just to get max benefit. He was wondering once it had been 2 days, does it not matter if you take any anti-inflammatory.     Follow up (05Nov2021): This is a follow up spontaneous report from a Pfizer Sponsored Program.  The lot number for the vaccine, [COMIRNATY], was not provided and will be requested during follow up.  Follow-up (10Nov2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Information has been received from a licensed practical nurse concerning a 9 year old black/white male with no known allergies who on 08/13/2004, at 14:45, was vaccinated subcutaneously in the left thigh with the first dose of varicella virus vaccine live.  The LPN reported that on 08/22/2004 the patient developed a red, slightly raised area at the vaccination site.  Subsequently, the patient recovered from the red, slightly raised area at the vaccination site.  No further information is available.
Pt was seen by Dr. for a physical on 9/17/2018. Dr. ordered a Tdap and PNEUMOVAX 23. Prior to administration the patient and daughter were counseled by Dr. and were also given copies of each VIS (vaccine information sheet) to review and take home. Per pt request both vaccines were administered in the L deltoid. Pt called office the following day Tuesday 9/18/18 stating that she was experiencing pain and swelling on her L arm. Pt denied rash, difficulty breathing, and fever. Advised pt to apply ice and take ibuprofen to help with pain and swelling and if she developed any additional symptoms she should be seen. Pt expressed understanding. Several days later Friday 9/28/18. Patients daughter stopped into office to inform me that her mom (the patient) was in the hospital due to a "reaction or infection" from the vaccine. Daughter confirmed that pt never developed a rash or difficulty breathing but swelling was worsening and when temperature was checked at hospital she did have an fever.
Breathing changed (was more labored) for about 48 hours.  Inside of my nose felt swollen, my tongue felt swollen, my lips were tingly, and my finger tips were tingly for about 4 hours.  Left side of my body hurts from the top of my head to the tips of my toes.  For about 4 days I could not tough my neck because the pain was so intense.  I had a hard time eating because my jaw hurt to chew.  My rib cage hurts to breathe.  Can't lay on my left side because the pain is so severe.  On day 7 my knee swelled up and had to be drained.  Can't bend my knee because the swelling is so much.  After a week the swelling has started to go down, but still swollen and very concerning.  I have felt feverish everyday but only had a fever the first two days.  I get waves of feeling weak and dizzy every day.
Left side chest pain, hypertension, tachycardia for 21 days after second dose of vaccine
9 days after first dose I noticed a large rash around the injection site. I had soreness the day after receiving the vaccine but no other problems until yesterday. The rash is very prominent and warm to touch.
pt presented to clinic w/pain & tenderness in arms & legs along w/edema that cont to spread to back & neck over next several wk;pt sent to MD neuro end of NOV;dx inflammation myositis secondary to adverse vax rxn;
Experiencing intermittent shortness of breath, heart palpitations, chest pain since receiving the 2nd dose. Experiencing longer, heavier, more painful menstrual cycles since receiving the 2nd dose.
C/o lethargy & fever & vomiting within hours of vaccine. Temp up to 103 degrees & fussiness. Tx with TYLENOL/MOTRIN.
received vaccines after a temperature excursion; This non-serious case was reported by a other health professional and described the occurrence of incorrect storage of drug in a 16-year-old patient who received DTPa (Reduced antigen) (Tdap Vaccine) (batch number 57GJ2) for prophylaxis.   On 24-JAN-2023, the patient received Tdap Vaccine. On an unknown date, an unknown time after receiving Tdap Vaccine, the patient experienced incorrect storage of drug (Verbatim: received vaccines after a temperature excursion). The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK receipt date: 14-Apr-2023 The reporter consented to follow-up. This case was for one of 119 patients, reported by same reporter. The patient received unstable vaccine after a temperature excursion, which led to incorrect storage of drug.; Sender's Comments:  US-GSK-US2023054677:same reporter US-GSK-US2023AMR055743:same reporter
sneezing, drippy runny nose, nasal congestion, sore throat, headache
Initial report was received on 11 October 2010 from another manufacturer, report number WAES 1009USA05059. The initial reporter to this manufacturer had been a medical assistant. Verbatim from the report: "Information has been received from a medical assistant concerning a 67 year old female patient with no pertinent medical history and no drug reactions or allergies who on 22-Sep-2010 was vaccinated intramuscularly in the right arm with a 0.5 ml dose of PNEUMOVAX 23 (Lot# 665902/1426Y) (Expiration date: 02-Jul-2011). Concomitant therapy included JANUMET, magnesium (unspecified), COLACE, LIPITOR, PREVACID, LANTUS, lisinopril (manufacturer unknown), LEXAPRO and FLUZONE. The medical assistant reported that on 23-Sep-2010 the patient experienced fever, fatigue, upper arm from shoulder to elbow was swollen, hot and very painful. The medical assistant stated that the patient received FLUZONE in the same arm as PNEUMOVAX 23. There were no laboratory tests or diagnostic studies performed. At the time of the report, the patient's outcome was unknown. The patient sought medical attention by an office visit on 24-Sep-2010. Patient's fever, fatigue, upper arm from shoulder to elbow was swollen, hot and very painful were considered to be disabling by the medical assistant because could not move her arm. This is one of several reports from the same source. Additional information has been requested." Of note: this report included coding for the event of drug administration error; however this was not specified in the report. Documents held by sender: Merck WAES report.
This case was reported by a other health professional via call center representative and described the occurrence of pain in arm in a patient who received SHINGRIX. In March 2018, the patient received SHINGRIX. In March 2018, less than a month after receiving SHINGRIX, the patient experienced pain in arm and mobility decreased. On an unknown date, the outcome of the pain in arm and mobility decreased were unknown. It was unknown if the reporter considered the pain in arm and mobility decreased to be related to SHINGRIX. Additional details were reported as follows: This case was reported by a pharmacy technician who was relative of the patient. The age at vaccination was not reported. The pharmacy technician stated on online chat that, the patient received the SHINGRIX vaccine about 7 to 10 days ago in right deltoid. The patient claimed to have had a reaction (not anaphylaxis) to the SHINGRIX vaccine. The patient experienced arm pain and could not move it because it hurted. The reporter could not provide address of facility, patient details, or other information and closed the chat before information could be given.
Developed itchy hives.  Have had them since they appeared. No treatment sought. I occasionally give in and scratch them (smile).
flushing, tongue tingling, redness chest, neck and cheeks. Evaluated by EMS-Cleared
Narrative: 72yo male patient died on 6/10/2022 of unknown cause, unknown circumstances. Pt had not received care from this facility since April 2022. Pt received medical care at other health system. Pt had received a covid vaccine (J&J EUA) on 5/26/2021. Likely this vaccine is not related to pt's death given pt's age & comorbidities. See pt's problem list below. Report submitted due to EUA status of vaccine. ST PROBLEM LAST MOD PROVIDER A Long-term current use of insulin 09/29/2020 (ICD-10-CM Z79.4) A Anemia (ICD-10-CM D64.9) 09/22/2020 Benign essential hypertension 06/18/2019 (ICD-10-CM I10.) A Diabetes mellitus (ICD-10-CM 10/29/2015 E11.65) A Folliculitis (ICD-10-CM L66.2) 10/29/2015 A Other specified diseases of hair and hair 11/21/2013 follicles (ICD-9-CM 704.8) A (ICD-9-CM 311.); Depression * (ICD-9-CM 04/30/2008 311./300.4) A (ICD-9-CM 784.0); Headache * (ICD-9-CM 784.0) 01/30/2007 (ICD-9-CM V65.9); Health Maintenance (ICD-9-CM 09/28/2006 V65.9) A (ICD-9-CM 401.9); Hypertension, Essential 05/22/2006 A (ICD-10-CM E78.5); Hyperlipidemia (06/01/2018) A (ICD-9-CM 368.9); Disorder, visual NEC (ICD-9-CM 05/22/2006 368.9) A (ICD-9-CM 305.1); Tobacco user 05/22/2006 (ICD-9-CM 682.9); Abscess * (ICD-9-CM 682.9) 07/02/2004 (ICD-9-CM 250.00); Diabetes Mellitus * (ICD-9-CM 07/02/2004 250.00)
feels weak; doesn't feel good at the moment; tired; headache; soreness in her arm; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (feels weak), FEELING ABNORMAL (doesn't feel good at the moment), FATIGUE (tired), HEADACHE (headache) and VACCINATION SITE PAIN (soreness in her arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unk) for COVID-19 vaccination.     No Medical History information was reported.    On 03-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ASTHENIA (feels weak), FEELING ABNORMAL (doesn't feel good at the moment), FATIGUE (tired), HEADACHE (headache) and VACCINATION SITE PAIN (soreness in her arm). At the time of the report, ASTHENIA (feels weak), FEELING ABNORMAL (doesn't feel good at the moment), FATIGUE (tired), HEADACHE (headache) and VACCINATION SITE PAIN (soreness in her arm) outcome was unknown.            No concomitant drugs were reported. No treatment drugs are not provided by reporter.   This case was linked to MOD-2021-075839 (Patient Link).   Reporter did not allow further contact
Patient had fainting episode shortly after the shot. She fell and hit her R shoulder and R ear--she was placed lying down on exam table. Given water and tylenol; she felt better after 20 minutes. She declined any xrays or ER. Wanted to go back to work. R clavicle mild abrasion, R pinna-blood from earring, stopped on own. Headache continued so patient had a head CT scan. It was positive for concussion, she was given head injury precautions.
Patient only had primary series dose 1 of monovalent. Monovalent has been discontinued and there is no further direction and medical assistant administered bilvalent booster 12+ as the second dose.
mom rpt child having red area both thighs, & crying for 45 min. no fever, phone call to ER, told her it was allergic react.
Headache, dizziness, itchy & watery eyes, sneezing, intermittent fever/chills, body aches, hoarseness, sore/scratchy throat, fatigue, difficulty taking deep breath after exertion.
facial swelling w/numbness inc t101-102; APAP & DPH given by MD;
3/13/2021 Taken to ER  via ambulance due to tingling then numbness of the tongue, rapid heart rate, extremely elevated heart rate.  Since then on going  constant left leg pain, rapid heart, spike in blood pressure, headaches, dizziness, shortness of breath and intermittent uncontrolled muscle movement in hands and face.
This spontaneous report as received from a registered nurse refers to 4 patients of unknown age and gender. No information regarding the patients' medical history, concurrent conditions or concomitant therapies was reported. On an unknown date, the patients were vaccinated with improperly stored (temperature 47.5 Fahrenheit degrees (F), for 16 minutes) doses of GARDASIL 9 (lot # L019297, expiration date 18-AUG-2017, dose and route of administration were not reported). No adverse symptoms were reported. There was no previous temperature excursion. The call was made because of data logger. This is one of two reports received from the same reporter. Additional information has been requested.
This initial spontaneous report was received from a Certified Medical Assistant (CMA) and refers to a male patient of unknown age.  Medical history, concurrent conditions and concomitant medications were not provided. On 07-JUN-2017, the patient was administered an expired dose of VAQTA 50/1.0 U/ml (route not provided) (lot # M022556; expiration 26-MAY-2017). No adverse reactions were reported. No further information was provided. Additional information has been requested.
Pt mentioned to staff Rph approximately 3/17 that his arm was still sore. Rx M tried to call pt. Left message pt. came in Mon 3/23 and said arm was sore after injection and has been sore since. Also when hold arm out to side and elevates it. Also when he sleeps at night. I advised him to seel medical attention as that is not a normal side effect.