chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from the patient's mother, concerning her child of unknown age and gender. On an unknown date the patient was vaccinated with a dose of M-M-R II (lot #, dose and route not reported). Concomitant therapy was not reported. The reporter stated that on an unknown date her child had serous side effects after receiving M-M-R II. The patient had a different set of symptoms, high fever and  lymph node problems, the child underwent many tests (data not reported) and an unspecified health care professional determined that it was a reaction to the M-M-R II. The outcome of reaction to the M-M-R II, high fever and lymph nodes problems was unknown. This is one of several reports received from the same reporter: MARRS: 1407USA000508 and 1407USA000509. Additional information is not expected.
March 3,2020 patient received Restylane filler in tear troughs under eyes. 48 hours following COVID vaccine filler under right eye became swollen, painful.
Information has been received from a physician concerning a 9 week old female who on 13-AUG-2008 was vaccinated PO with the first dose of ROTATEQ. On 16-AUG-2008 the patient developed severe vomiting and diarrhea that lasted for a week. The patient underwent an ultrasound that was negative. The patient sought medical attention at an office visit. The patient recovered fully. A product quality complaint was not involved. Additional information has been requested.
pt recvd vax; 4 hrs later exp 9.5x7cm local erythema, induration, swelling, tenderness & fever; md expressed a concern for the particular lot;
Redness next to the injection side.  Is the size of a quarter and is tender to the touch.
p/vax recv vax pt passed out & fell fr chair to floor. appeared bewildered, bp 98/56, p60 r16. pt c/o weakness & fatigue, mildly confused. upon leaving clinic pt still c/o of weakness & fatigue. needs support while ambulating. @ home slept
Sweating; Headache; Nausea; Restlessness; Hot flashes; This is a spontaneous report from a contactable consumer, the patient. A 34-year-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3247) via an unspecified route of administration on 22Mar2021 at 09:30 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. The patients medical history was not reported. The patient was allergic with penicillin. Prior to 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. Concomitant medications included vitamin C (MANUFACTURER UNKNOWN), vitamin D (MANUFACTURER UNKNOWN) and biotin (MANUFACTURER UNKNOWN). On 23Mar2021 at 06:00, the patient experienced sweating, headache, nausea, restlessness and hot flashes. The patient did not receive any treatment for events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of events sweating, headache, nausea, restlessness and hot flashes was recovered on an unknown date in Mar2021.   No follow-up attempts are needed. No further information is expected.
Patient complained of numbness in arm of injection site. Arm looked slightly swollen and splotchy red. The nurse assisting with the clinic assessed it and decided to give him benadryl. This was 10 to 15 minutes after shot was given. Patient stated he was not feeling will, started look light headed and dizzy. As his condition did not to seem to improve after sitting down for 5 to 10 minutes and ambulance was called.  Paramedics arrived and took him to the hospital. The total time between first onset of complaint and EMTs taking patient away was between 30 to 45 minutes.
pt recvd vax; rt arm was sore & red w/ redness spreading to cover upper arm to elbow; very tender to touch, painful; pt cried due to pain; pt given AB for bacterial infection;warmth at injection site;
Immediate-rash face, arms, chest, back, legs;-MD notified ordered DPH 1/2 tsp Q4 till AM 21MAR f/u as needed;
Multiple irregular erythematous lesions - burning and tingling on both forearms . Next day  a 1 cm bullous lesion developed on the left  forearm and following day , a half centimetre bullous  lesion  over another erythrmatous lesion on the right knuckle . Cross referenced on line with symptoms and record of similar symptoms . Most responsible diagnosis was erythema multiforme.  This is considered an autoimmune phenomenon to vaccines. Incidentally I have a history ( pathology confirmed ) of Hashimoto?s thyroiditis in 1974. I have never had EM episode. I am a retired physician  and feel confident in the diagnosis .
A report was received from an office manager on 20OCT2003 and validated by a health care professional on 21OCT2003 concerning a 2 year old male vaccinee who received Fluvirin on 20OCT2003. On 20OCT2003 the two year old vaccinee received Fluvirin. There was insufficient information to determine the reporter's causality assessment. Follow up pending.
Patient was seated for Shingrix vaccine. I talked to patient for a few minutes after administration then she stood up from chair and walked to register. While waiting in register line she stated "I think I need to sit down".  I recognized patient was about to faint and caught her while she was walking back to the immunization area.  Kept patient laying on ground for approximately 5 minutes and then moved patient to chair. Patient stated she had fainted in the past when giving blood but never from a vaccine. She stated that she thinks she fainted from "getting worked up about the vaccine and the pain she felt". I moved patient to chair when she was ready and store manager gave her orange juice. She sat in chair for another 5-10 minutes. Patient stated she felt fine so the store manager and I walked her to her car. She stated she was going to sit in her car with the air conditioning on for awhile. Spoke to patient an hour after event and she said she felt fine just had the expected arm soreness.
p/vax pt started to run temp; to ER & adm;T104.8 refused liquids or food, vomiting, colicky;
About 12 hours after receiving the second dose of the Moderna COVID vaccine, I began experiencing flu-like symptoms including all-over body aches, chills, low-grade fever, and headache. I was unable to sleep much that night. Nausea set in in the late afternoon of the next day in addition to fatiuge. I woke up on Friday, and about 48 hours after the shot, I became very nauseous, and experienced several hours of vomiting and diarrhea. I called my primary care doctor in the afternoon to inquire whether these symptoms were normal and she prescribed me a low dose of Zofran to curb the vomiting. The following day, Saturday, I continued taking Zofran since I was still quite nauseous though no longer vomiting and had a splitting headache. By Sunday morning, I felt marginally better and was able to eat and drink a little.
Got my 2nd Moderna shot on 2/12/21 at 3:00. At about 7:00 pm I developed incredible pain in my right side of my jaw. I could not bite down on not bite down with my teeth and could barely eat (on the left side of my mouth).  With some  Advil, I was able to sleep (poorly). This lasted for two more days then went away.  On 3/14/21 it began to recur but very mildly. This also lasted 2 more days then went away On 3/18/21 I had a dental appointment (not because of this - just routine). The dentist felt my reaction was totally related to the shot and not my teeth (which are in bad shape).
Patient was administered KINRIX intramuscularly in the left thigh and PROQUAD subcutaneously on the right thigh on 8 Mar 2016. After vaccination, patient was seen in office on 10 Mar 2016 c/o swelling and redness at injection site left leg. Per Physician Assistant notation: Pt has large area of swelling to left mid thigh.
Slight itching after injection (shortly after), next day redness and soreness about size of silver dollar. Itching, mild, continued for about 10 days. Redness lasted 5-7 days.
From telephone triage note on 1/5/10:  "Vet called to report Adverse Reaction to the H1N1 vaccine that was  administered to the vet on 12/30/09. The vet reports that he immediately got chills and subsequently a pulmonary infection x 4 days. "
Feeling of shortness of breath; Tachycardia; Sweating; Hot; Pregnant/ Gestational period: 16; This is a spontaneous report from a contactable nurse (patient). This is a maternal report. A 34-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EL3247), via intramuscular, administered in left arm on 09Feb2021 14:15 (at the age of 34-year-old) as dose 1, single dose for COVID-19 immunisation. Medical history included pregnant and COVID-19 from an unknown date. Patient had no known allergies. Other vaccine included in two weeks doxylamine succinate, pyridoxine hydrochloride (DICLEGIS). The patient did not receive other vaccine in four weeks. Post vaccination, the patient had not been tested for COVID. On 11Feb2021 at 08:00, patient experienced feeling of shortness of breath, tachycardia, sweating, hot. Treatment was not received in response to the events. The mother reported she became pregnant while taking bnt162b2. The mother was 16 Weeks pregnant at the onset of the event. The mother was due to deliver on 24Aug2021. Outcome of the events was unknown.
This spontaneous report as received from a nurse refers to a 2 year old patient of unknown gender. The patient's relevant medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 19-SEP-2017, the patient was vaccinated with improperly stored VAQTA (dosing details were not reported) (lot # N008823, expiry date: 26-MAY-2018) for prophylaxis (incorrect product storage). No adverse effects were reported. Temperature excursion was from 0 degree Celsius (C) to 1 degree C (0.8 degree C) for 52 minutes. The previous temperature excursion was reported as 9 degree C to 25 degree C (10.9 degree C) for 3 hours 17 minutes. The call was because of a data logger. No product quality complaint involved. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1709USA007011: US-009507513-1709USA007012: US-009507513-1709USA007013: US-009507513-1709USA007014: US-009507513-1709USA000054:
Received vaccine almost 1:10PM, went to post observation. 5 min past, begin to cough and go out to lobby. Followed out and returned to  observation area. C/o dizziness and dry throat and continue to cough. Placed on stretcher. V/S taken: 143/93 HR88 No SOB noted on C/O.  Monitored patient until 2:30PM. Escorted to car with family. No distress . Instructions given per RN.
A few hours after her PNEUMOVAX booster (received 1 around age 60, she was 67 with this one) her left arm started to swell, get red, and was very painful.
01/09/22 presents to EC ED for "SOB on exertion with cough and fatigue" "positive for COVID on 1/4 at an Urgent care". PMHx of "CAD, HTN, MI cc"
930AM sore throat, nausea & fatigue beginning 1 1/2 hrs p/vax; 1130 cont to exp sore throat & fatigue;
Information has been received from a female patient who was vaccinated with a dose of pneumococcal vaccine 23 polyvalent (manufacturer unknown). The patient stated that she had an allergy to  the pneumococcal vaccine. The patient also reported an experience with alendronate sodium (WAES01072401). Additional information has been requested.
injection site pain and warmness; injection site pain and warmness; injection site redness, swelling, itching; injection site swelling; injection site itching; headache; joint aches; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 8th December 2019, the patient received the 2nd dose of Shingrix. On 9th December 2019, 1 days after receiving Shingrix, the patient experienced injection site erythema, injection site swelling, injection site itching, headache and joint pain. On 10th December 2019, the patient experienced injection site pain and injection site warmth. On 10th December 2019, the outcome of the joint pain was recovered/resolved. On 11th December 2019, the outcome of the headache was recovered/resolved. On an unknown date, the outcome of the injection site erythema, injection site swelling, injection site itching, injection site pain and injection site warmth were not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema, injection site swelling, injection site itching, headache, joint pain, injection site pain and injection site warmth to be related to Shingrix.  Additional details were provided as follows: The patient received dose of Shingrix in the left arm. After vaccination the patient had injection site redness, itching and swelling and joint aches and a headache and developed injection site pain and warmness. The patient reported that, the injection site reactions have all improved, but are still there. The reporter consented to follow up.
Initial information received on 11-Mar-2019 regarding an unsolicited valid non-serious case received from other health professional. This case is linked to cases 2019SA071131, 2019SA071150, 2019SA071151, 2019SA071152, 2019SA071153, 2019SA071154, 2019SA071146, 2019SA071147, 2019SA071155, 2019SA071149 and 2019SA071156 (same reporter). This case involves a pediatric patient of an unknown demographics who was accidentally administered with FLUZONE HIGH DOSE lot UJ043AB via unknown route in unknown administration site instead of FLUZONE QUADRIVALENT on an unspecified date. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It is an actual medication error case due to wrong vaccine administered, inappropriate age of vaccine administration and overdose. No side effects had been reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
It was reported that a 44 year old female patient received a Fluzone SV '01-'02 vaccination administered in left deltoid. The patient reported 11/07/01, she developed swollen lymph nodes that became painful. A physician evaluated patient and it was felt that the patient had lymphadenopathy with possible lymphadenitis. No treatment prescribed resolved.
myelitis, left leg numbness and weakness, started 9 days after influenza vaccination.  Syndrome confirmed by neurologist and neurosurgeon.  Treatment: Steroids
Tingling in left arm through finger tips for 30 minutes.; Pain at and around injection site; rash at and around injection site; swelling at and around injection sites; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration in the left arm on 09Apr2021 at 10:15 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. Medical history included diabetes, high blood pressure, liver fibrosis, high cholesterol and COVID-19. The patient was allergic to latex. The patient was received medications (not specified) within two weeks of vaccination. The patient previously took erythromycin (MANUFACTURER UNKNOWN) and niacin (MANUFACTURER UNKNOWN), for unknown indications and on unknown dates, and experienced drug allergy. Prior to the vaccination, the patient was 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 09Apr2021, at 10:30 the patient experienced tingling in left arm through finger tips for 30 minutes, pain, rash and swelling at and around injection site. The patient had applied ice still the pain, rash and swelling at and around injection site was present (more than 72 hours later). The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the event of tingling was recovered, on 09Apr2021 after the duration of 30 minutes; while that of the clinical outcome of the events of pain, rash and swelling at and around the injection site was not recovered at the time of this report.    No follow-up attempts are needed. No further information is expected. .
Patient presented for Pfizer vaccine. Prior to immunization he appeared to be very  nervous and reported he was having a lot of anxiety. He was accompanied with his wife who reports he was very nervous. Pt confirmed no allergies, not in quarantine, being sick, and denied any medical problems. Pt tolerated the vaccine while and walked with his wife to the waiting room. After about 5 minutes in waiting room, his wife yelled out "I need help." Nurse was first on scene and instructed the clerk to call 911. Nurse was in unit and assisted in care, checking BP and pulse (90/50 and 64). Pt was diaphoretic and pale, oxygen administered and patient monitored until EMTs arrived. Once arrived patient had started to come around, color returning and not as sweaty. He got up and walked to stretcher and exited with EMTs and wife who followed after.
Vaccine was expired on 01-Apr-2022, refrigerated on 04-Apr-2022 and administered on 04-Apr-2022; Expired vaccine administered to the patient; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to the patient) and PRODUCT STORAGE ERROR (Vaccine was expired on 01-Apr-2022, refrigerated on 04-Apr-2022 and administered on 04-Apr-2022) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 04-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to the patient). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was expired on 01-Apr-2022, refrigerated on 04-Apr-2022 and administered on 04-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to the patient) and PRODUCT STORAGE ERROR (Vaccine was expired on 01-Apr-2022, refrigerated on 04-Apr-2022 and administered on 04-Apr-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The vial was initially stored in the refrigerator on 04-Apr-2022. The vial did not undergo any temperature excursions. It was reported that pharmacist thought that the vaccine expired in Jun-2022, however it was expired on 01-Apr-2022.  No treatment information was reported.
he had an episode which he states is similar to a TIA (transient ischemic attack); Reports experiencing something similar last may except for 'the paralysis'.; numbness,  pain and tightness in his lower half of his body which was  more prominently felt  on his left side.; numbness,  pain and tightness in his lower half of his body which was  more prominently felt  on his left side.; numbness,  pain and tightness in his lower half of his body which was  more prominently felt  on his left side.; States he felt as though his knee had a tear in it- it felt it was on fire; tightness in left knee; shortness of breath; feeling foggy; headache; balance issue; coordination off; having  a hard time to get a sentence out (felt like his motor skills were affected); having  a hard time to get a sentence out (felt like his motor skills were affected); confusion; blurred vision; impending sense of doom; post fatigue; his energy doesnt feel up to par; This is a spontaneous report from a contactable consumer (patient) reported for himself. A 28-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 19Apr2021 at 28 years old (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient stated that on 19Apr, he had the first shot of pfizer covid vaccine. This past sunday (25Apr2021), he had an episode which he stated was similar to a TIA (transient ischemic attack). Reported numbness, pain and tightness in his lower half of his body which was more prominently felt on his left side. Stated he felt as though his knee had a tear in it- it felt it was on fire; he experienced burning and tightness in left knee. He also reported having shortness of breath, headache, feeling foggy, balance issue, coordination off, having a hard time to get a sentence out (felt like his motor skills were affected), confusion, blurred vision and an impending sense of doom. Stated this episode persisted for 15 min and then it resolved. Currently he was experiencing a 'post fatigue' and his energy didn't feel up to par. Reported experiencing something similar last may except for 'the paralysis'. Had not followed up with his provider. Patient was scheduled for second shot of Pfizer covid vaccine on 10May, he was asking for information if he decided to delay his second shot past may 10th. He was asking for information on getting the second shot given his recent experience possibly related to the vaccine shot. Was not sure if he should get the second shot. He was asking about side effects for the second shot- if it would be worse. Asking if there were any reports of blood clots with Pfizer covid vaccine. The outcome of the events 'post fatigue' and "his energy didn't feel up to par" was unknown, of other events was recovered on 25Apr2021.  Information about lot/batch number has been requested.
Patient stated was anxious before getting vaccine. About 5 minutes after vaccine given stated upset stomach, hands sweaty, hands tingling, felt like fainting. After about 10 minutes patients symptoms resolved.
The vaccinator thought there was vaccine in the syringe when in fact there was nothing in the syringe being used. The Patient received less than 0.5cc of air.
Initial misuse report received on 09 September 2013 from a health care professional. A 2 day old patients whose gender, medical history and concomitant medications were not reported, received a dose of ADACEL (lot number, route and site of vaccination was not reported) in error. As of 04 October 2013, the patient did not have any adverse events. List of documents held by sender: none.
-Mastitis of left breast despite not nursing and no visible trauma/cuts, ultrasound to rule out abscess, one 7 day round of antibiotics. Started red, warm and a lump under the skin. After antibiotics, discoloration remains and lump has subsided but thickened tissue remains.  -Swollen lymph nodes in left arm after injection, lasted for a few days and then subsided.  -Swollen lymph nodes in groin appeared about a month after injection. Dr checked and determined they were likely reactive nodes to some sort of local infection/inflammation but no obvious infection appears. -Joint pain throughout body, especially legs and hands, persists off and on even now, 6 weeks after the vaccine.
I started vomiting first, only one time  nausea and  chills until 1 pm and headache until 6 pm. around 8 pm I was feeling almost back to normal