chrisvoncsefalvay/vaers-outcomes huggingface dataset:
DYSPHONIA/voice was weak; This spontaneous case was reported by a consumer and describes the occurrence of DYSPHONIA (DYSPHONIA/voice was weak) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product EDARAVONE (RADICAVA) injection for Amyotrophic lateral sclerosis.    Concurrent medical conditions included Amyotrophic lateral sclerosis since August 2021 and Wheelchair user.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient started EDARAVONE (RADICAVA) (unknown route) at an unspecified dose. On 10-Mar-2021, the patient experienced DYSPHONIA (DYSPHONIA/voice was weak). At the time of the report, DYSPHONIA (DYSPHONIA/voice was weak) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant and treatment drugs were not provided   This case was linked to (Patient Link).   Reporter did not allow further contact
patient was vaccinated at ~9:50 am. Daughter decided to give patient an ibuprofen "just in case she had side effects" around 12:30-1:00. Shortly thereafter, patient started to itch on scalp and palms of hands and "a couple" of hives noted on back. patient was advised to take a benadryl. Daughter reports that one hour later, patient is symptom free. Advised to call pcp to report this, as patient may be allergic to the ibuprofen. Patient does not usually take ibuprofen.
Pt had rash but not the injection site . It is lower and to the right. Dr. prescribed triamcinolone 0.5% cream.
The patient was given his first dose of the vaccine around 5:07. Afterwards, he came out of the waiting room to the front of the pharmacy counter and said he feels weird. The patient then collapsed and hit his head. I responded to his side and he came to. Very shortley after, his eyes rolled back into his head. He was turning read, and had significant buldging in his neck. His breathing was very labored and making a strider like noise. I adminstered an epi-pen at 5:09 pm into his right outer thigh and he immediately started breathing and coming to. He remained stable until EMS arrived and was transported to the hospital.
HYPOTENSION ACUTE ON CHRONIC RESPIRATORY FAILURE ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE 6/23/2022 &  8/11/2022  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
pt recvd vax 11AUG92 & became rigid w/arms above head, body bowed backwards & eye rolled back following last inject; face pale, blotchy skin @ site of both injections; immed became limp & revived;
Received the first and second dose of the Covid-19 vaccine as well as the booster dose. Unfortunately, she tested positive with covid; Received the first and second dose of the Covid-19 vaccine as well as the booster dose. Unfortunately, she tested positive with covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "Received the first and second dose of the Covid-19 vaccine as well as the booster dose. Unfortunately, she tested positive with covid". The patient had both of her Pfizer shots and she had both of her booster shots and went Tuesday and she tested positive.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
COVID vaccine made me incredibly sick/Sick; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID: (RA). The reporter is the patient.  An adult female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "COVID vaccine made me incredibly sick/Sick".  Additional information: COVID vaccine made the patient incredibly sick; therefore she was skeptical of any vaccines for COVID.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient made an online appointment despite being underage. No adverse effects were observed however, the patient is under 16 year old which is under the current accepted guidelines for Pfizer COVID-19 vaccine.
Pt called into the telephone triage service on 10/08/2019 stating that he had a pink, itchy rash for 3 days after receiving his dose of the Shingrix vaccine on 10/03/2019. The patient said during the call that the injection site area still itched, but his other symptoms resolved. The patient did not use any agent to relieve his symptoms.
I had my second SHINGRIX injection at lunchtime on 11-9-18 (had first one on 8-14-18). The injection itself was quite painful and felt as though it even went in so deep it hit my bone! I have redness and pain at the injection site that started on 11-10-18. About 2:00 AM on the 10th I awoke feeling ill, with a fever of 101, chills, headache, severe body muscle aches, nausea and generally feeling poorly. The fever and chills and nausea lasted for 24 hours but the headache and body aches for 48 hours, and then I developed diarrhea on 11-11-18 which only lasted a few hours.
This case was reported by a nurse via other manufacturer and described the occurrence of pain in arm in a adult patient who received Shingrix for prophylaxis. On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than a year after receiving Shingrix, the patient experienced pain in arm, swelling arm and erythema of extremities. On an unknown date, the outcome of the pain in arm, swelling arm and erythema of extremities were unknown. It was unknown if the reporter considered the pain in arm, swelling arm and erythema of extremities to be related to Shingrix. Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported, but was captured as adult as per the vaccine indication. The case was received from other manufacturer's medical representative, who provided the information reported by the nurse. The nurse reported that the patient received Shingrix and experienced painful and red swelling on the arm. No additional information was provided. This case has been linked with case US2018GSK148212, reported by the same reporter.
pt recvd vax 7JAN93 & devel rash on abdo which disappeared in a few days;
AE: patient has racing heart rate 10 minutes post vaccine administration. Treatment: no medication was given. patient was under observation.  Water improved symptoms Outcome: symptoms resolved and patient was sent to healthcare facility.
Information has been received from a consumer concerning her husband who on approximately 23-JUN-2008 was vaccinated with a dose of ZOSTAVAX (Merck).  The consumer reported that her husband experienced some slight swelling and itching on his arm.  At the time of reporting, the outcome of the patient was unknown.
Systemic: Fainting / Unresponsive-Severe, Systemic: Seizure-Severe, Systemic: Shakiness-Severe, Additional Details: Received vaccine at 2:14 pm, moved to chair at 2:14:30, leaning forward in chair. Squatted next to companion at 2:15:20 for ~1 min. Seated again at 2:16:30, leaning forward. Rubs head at 2:18, held head at 2:18:30. At 2:19:30 pulled arms up bent at elbow, shook for 5 sec, fell out of chair, hit head, shook for 5 more sec, regained consciousness.
I don't know for sure this was from vaccine but thought I should report. Eight days after vaccine my left arm went totally numb, then my right hand and my right foot. My family checked me for a stroke. I was speaking clearly, no blurred vision. could smile and lift both hands evenly. A nurse friend checked my vitals, pulses in arms and feet and circulation. All ok. That has never happened before or since which made me question if it was vaccine related. It lasted about an hour and went away
This spontaneous report as received from an office manager refers to a 4-year-old female patient. Her medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported. On 02-APR-2018, the patient was vaccinated with a dose of VARIVAX (dose, route and site of administration, lot number and expiration date were not reported) that was reconstituted with an improperly stored sterile diluent (dose, route and site of administration were not reported, lot # M009799, expiration date: 11-SEP-2018). The sterile diluent was stored in temperature below 32 Fahrenheit degrees (F) (-11 F) for 120 hours. There was a previous temperature excursion of 32 F up to 35 F (34.5 F) for 45 minutes. Temperature excursion occurred as a result of a reading from a Digital Data Logger. It was confirmed that VARIVAX had no temperature excursion prior to being administered. No adverse effects were reported. This is one of several reports received from the same source. Sender's Comments: US-009507513-1804USA004764: US-009507513-1804USA013049.
7hr p/vax pt across mom lap waking from nap & body shot straight up as if to stand;head kicked back;turned beet red & eyes bulged out as head shook & could not breathe x few seconds;pt taken to ER;
Red, feverish swollen arm, purple in spots, rash all down arm--Instructed patient to take diphenhydramine and ibuprofen, apply ice pack for 15 min at a time, and if continues after a week from vaccination, see a medical doctor.
ZOSTAVAX was administered. Exp on box 3/7/14, after administration, noticed that real exp 3/13.
This spontaneous report as received from a certified medical assistant refers to a multiple unspecified patients of unknown age and gender. No information on patients' medical history, concurrent conditions or concomitant medications was provided. On an multiple unspecified dates, the patients were vaccinated with improperly stored unspecified doses of RECOMBIVAX HB injection, lot# K020216 with expiration date 17-SEP-2016, lot# reported as L0014156 with expiration date 22-OCT-2016, lot# L004754 with expiration date 10-NOV-2016, lot# L016427 with expiration date 13-APR-2017, lot# L029631 with expiration date 14-AUG-2017 (dose and route of administration were not reported). No adverse effects were reported. This is one of the several reports from the same source. Additional information has been requested.
First, I got an extremely sore arm.  The arm was so sore I could not sleep because every time I moved it hurt enough to wake me up. The next day (~midday) I broke out in severe hives. At around 12.20 I became very, very sleepy and I lost my voice. At around 12.30 my partner noticed my face was swelling (around my jaw and cheeks).
Patient called on 2/17/23 and reports that he has been experiencing arm pain since receiving tetanus vaccination on 1/26/2023. Reports initially had swelling in arm after injection, now a knot remains at injection site. Reports arm tenderness, and decreased range of motion due to pain and ?like my arm doesn?t want to go anymore?.  Provider spoke with patient and discussed cold compress at injection site and anti-inflammatories. Advised to make follow up appt. for evaluation, but patient did  not schedule appt.
Narrative:  PT RECEIVED COVID PFIZER VACCINE ON 1/20 AND 2/10. HOSPITALIZED SEVERAL TIMES PRIOR TO HIS POSITIVE TEST RESULT ON 4/15 BUT MORE LIKELY DUE TO EXTENSIVE HISTORY OF EDEMA/ASCITES REQUIRING PARACENTESIS AND BLOODY BOWEL MOVEMENTS. HIS ONLY SYMPTOM REPORTED PRIOR TO TEST RESULT ON 4/15 WAS STRATCY THROAT.
This shot both times made me feel like I had the flu for 2 to 3 days. Severe body aches. Strangely enough both times it altered my mood and any little thing could send me into a rage attack.
Site: Bruising at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Vomiting-Mild, Systemic: Weakness-Mild, Additional Details: EMT/EMS called and patient had caregiver come pick him up
Pain initially stayed at the injection site for 2 days but spread from injection site to whole arm and lasted for three weeks.  Nerve pain was noticed two days later when I shook someones hand.  It felt like a crushing sensation, and I could not fully use my hand.  Any level of pressure was painful and the weakness in my hand extended up my arm.  The best way I can describe the weakness was a loss of grip strength.  This lasted constantly for four weeks and lessened over the following three weeks.  Currently there is a loss of sensation in my right hand in addition to the existing neuropathy I've had since completing chemotherapy treatments in 2020.
numbness in lt hand. PT received J&J COVAX yesterday, came to ER today for work note to miss work today. Pt reports nausea and malaise, numbness to L pinky finger and lateral portion of hand. No other numbness/paresthesias/weakness.  20 yo otherwise healthy m c/o acute onset of numbness/tingling to L 4th and 5th fingers <24hrs perceived onset s/p J&J covid shot in L arm yesterday; Pt denies any pain, fevers/ns/chills, redness/warmth/swelling of fingers or at imms site on L shoulder, prior hx of similar sx's
The vial was initially stored in the refrigerator on 06-Oct-2022, the refrigerator expiration was on 06-Nov-2022 and date of administration was on 07-Nov-2022; No adverse event; Expired dose given/ Dose administered after 30-day Use By Date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired dose given/ Dose administered after 30-day Use By Date), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 06-Oct-2022, the refrigerator expiration was on 06-Nov-2022 and date of administration was on 07-Nov-2022) and NO ADVERSE EVENT (No adverse event) in a 29-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 063B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 07-Nov-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 07-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired dose given/ Dose administered after 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 06-Oct-2022, the refrigerator expiration was on 06-Nov-2022 and date of administration was on 07-Nov-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired dose given/ Dose administered after 30-day Use By Date), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 06-Oct-2022, the refrigerator expiration was on 06-Nov-2022 and date of administration was on 07-Nov-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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (Expired dose given/ Dose administered after 30-day Use By Date) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 06-Oct-2022, the refrigerator expiration was on 06-Nov-2022 and date of administration was on 07-Nov-2022).    No concomitant medication information provided. The vial did not undergo any temperature excursions. No treatment information provided.
Case number PHEH2011US008665 is an initial spontaneous report received from a physician on 04 Nov 2011: This report refers to an 11-year-old female child. She was given only the CYW-135 liquid component of MENVEO (batch number: M10057) intramuscularly on 20 Oct 2011. No other adverse event was reported.
Next day after vaccination patient reported weakness and shooting pain through arm where injection given. Today presents with vesicular rash on injected arm - photo taken.
Developed massive headache 1/2 hr ago, across my forehead and across the back of my head and neck. I rarely get headaches and never anything this painful. Just took ibuprofen
Continued pain of the left deltoid and some limited left arm movement.  Occasionally pain will radiate to left shoulder.  Able to freely move left arm forward and back.  Painful left arm abduction.  Pain started within minutes of injection and continues today (16 days later).  Limited medical evaluation by primary NP on 10/20/22.   No treatment provided.  NP suggested that time will heal and instructed to complete VAERS.
Information was received on 09-NOV-2016 from an unspecified reporter, reporting about a patient of unknown age and gender. The patient's medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB (strength, dose and route were not reported) with lot number M033096 (unspecified expiration date). No adverse experiences were reported. This is one of several reports received from the same reporter. Additional information is not expected, as follow ups requested to complete the case were received.
Ringing in ears; Slight headache; Moderate neck ache; General feeling of unease/anxiety; This is a spontaneous report from a contactable consumer, the patient. A 54-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 15Mar2021 at 01:15(at the age of 54-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Patient did not receive any other medications within 2 weeks of vaccination. The patient previously received ciprofloxacin (MANUFACTURER UNKNOWN) and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 22Mar2021, the patient experienced ringing in ears, slight headache, moderate neck ache and general feeling of unease/anxiety. The events did not result in doctor or other healthcare professional office/clinic visit/ emergency visit. Patient did not receive any treatment for the adverse event. The clinical outcome of the events ringing in ears, slight headache, moderate neck ache and general feeling of unease/anxiety were not resolved at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Woke up the night of the injection around 1am with chills & fever (102), no other symptoms/ Took TYLENOL, fever went down. Woke up about 7am (temp 99) feeling listless and achy. About an hour later became nauseous and had a fever of 102, which went up to 104 before TYLENOL kicked in. Began to feel pretty normal about 10:30 am. Temperature went up to 101 about 4pm, but otherwise felt OK. Took TYLENOL, temp went down. Took TYLENOL 6 hours later, just in case. No more problems. Had doctor's appt already scheduled the same day this was happening, and she felt sure these symptoms were a reaction to the SHINGRIX vaccine. With the first dose, I woke up with a fever that night, but no other symptoms or problems.
Wrong COVID vaccine was administered to the patient due to age.  Contacted the family recently and spoke with the sister who translated to both the parents; patient is okay and experiences no adverse reactions as of 5pm today.
Received flu vaccine IM (RA) on 10-9-12 at school. That night client stated he began itching / sl. redness on arm. Then Thursday morning was worse warmth / redness / swelling noted. To see Dr if worsens.
Patient given LAIV instead of IM injection due to clerical error.  Patient made aware and given educational material by Dr.
Headache, Sedation, Myalgia, Arthralgia, Fever, THROAT TIGHTENING SENSATION AND TINGLING TONGUE IMMEDIATELY AFTER VACCINE Narrative:
Patient came to pharmacy on 11/7/21 complaining that he could still not raise his right arm after receiving the covid shot on 10/17/21.  When asked to show where the shot was given he pointed to the center of the deltoid.  The technician that gave the shot also was asked to demonstrate where he gives the covid shot and he pointed at the center of the deltoid.
Arm hurts when raised past shoulder; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Arm hurts when raised past shoulder) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. FIN#349887743500) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ARTHRALGIA (Arm hurts when raised past shoulder). At the time of the report, ARTHRALGIA (Arm hurts when raised past shoulder) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment and concomitant medications were not provided by reporter.
This spontaneous report as received from a nurse refers to a 10 months 5 days old female patient. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) ROTATEQ lot # K016313, exp. date: 31-MAY-2016 and lot # K011663, exp. date: 20-MAY-2016 (dose and strength unspecified) oral. No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. All telephone attempts to obtain follow-up information had been unsuccessful. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
About 25 min after the vaccine was administered became lightheaded and face, neck, and chest turned bright red.
Dizziness, lightheaded at 12:30 pm, to the point of losing balance. Itchy arm at site of injection. Itchy bumps on arm for days/weeks after at site of injection. Extreme bone and joint pain at 1:00 am following the injection, that lasted for the next few days on and off. Dizzy spells continue sporadically to this date, on and off.
No additional AE reported; expired dose of MMR II was administered; This spontaneous report was received from a medical assistant, referring to a six-year-old patient. The patient's pertinent medical history, concurrent conditions, previous drug allergies or reactions and concomitant medications were not reported.  On 08-OCT-2021, the patient was vaccinated by accident with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) single dose, lot # S029581 was confirmed to be valid, expiration date 22-SEP-2021 (albumin status rHA) (exact dose, route and site of administration were not reported) for prophylaxis. No additional adverse events were reported.
I just started coughing up blood. I went to the ER and they found opacity in my lungs. I have to get a repeat CT scan to see if it cleared up if not they would go to the next step.