chrisvoncsefalvay/vaers-outcomes huggingface dataset:
She got her vaccine, did not have anything right away.  About 10 days later she started getting electrical shocks that started under her armpit on the right side, in the middle of her side, and a shooting pain would go to her nipple.  Since then the shooting pains that travel to her nipple from the side have slowed down, but her nipple is still very tender.  She also has noticed nodules/lumps in her breast which she has never had in the past.  Never had any problems with cancer or anything like that.  It has also caused some disfigurement of her breast due to the lumps/nodules and has about 5 or 6 of them.  Ever so often they hit her like a bolt of electricity.  The pain is still there, and can really make it a lot worse and go backwards if she does any activity especially reaching.  Within 10 minutes it hits her and stays with her for 1/2 a day or more.  She has no other reason to suspect that something else is wrong, and did hear about it on TV.    She has tried to get an appointment with an oncologist to get it checked out but nobody seems interesting in talking to her.  She is waiting for a call today to see if she can see one to find out if she's going to be OK or if it's going to turn into cancer.
Severe body aches Dizziness Nausea Fatigue  Diarrhea  Lasting for more than 1 week and debilitating to daily life
Pfizer-BioNTech COVID-19 Vaccine: We are reporting a vaccine administration error, NOT an adverse drug reaction. There was no harm to the patient as a result of the error. The error occurred on 1/11/2021 during the hospital's vaccination of co-workers for COVID-19. The co-worker in this report was vaccinated with a syringe containing air only and no actual vaccine. How the error occurred a first-time volunteer from critical care transport was assisting at the hospital's vaccine clinic with vaccine preparation and was observed correctly drawing up doses from the first vial. Error occurred when the volunteer drew up doses from the second vial. The volunteer drew up air only and no vaccine. How the error was discovered? An administrator thought the syringe felt strange and did not contain any vaccine. The error was discovered at that point. Investigation found that the volunteer had drawn up a total of 6 doses that contained air instead of vaccine and were dispensed for administration. Four vaccine syringes containing only air (and no vaccine) were recovered unused. Two vaccine syringes containing air (and no vaccine) had reached patients. This patient received one of the affected syringes but had already left the vaccine clinic when the error was discovered. She was told to return to vaccine clinic and receive a correctly prepared dose. Pt returned on 1/13 and got her dose [in left arm, Lot EL3248 1/13 0857]. Action? the vaccine clinic is taking greater care and additional time to confirm the skillset of the individuals who are first time volunteers at the vaccine clinic.
5-19-21 Patient self-reported to  that 8 days after receiving his first dose of Moderna (3/18/21), he began coughing up blood, was taken to the hospital, transferred to the ICU with thrombosis. He states he was in the ICU for 6 days. He then received second dose on 04/09/21 and was ill for 5 days again. States he currently remains fatigued, short of breath and "just not himself." Patient is concerned that the blood clots were related to his COVID Vaccines.
At checkout post observation period, recipient fell to floor from standing position, seizure observed, series of seizures observed, occurring every 1-3 min, 15-20 second duration, with increasing intensity.  BP 144/80 P 87  R 20.   O2 Via NC at 6 liters initiated. EMS arrived 1:07 pm.  EMS left to transfer to hospital at 1:14 pm. Recipient responding appropriately to commands before and after each seizure. Reported by caregiver that recipient has history of recurrent seizures.
Today was 3rd day of the Paxlovid after tested positive after having been vaccinated and boosted with Moderna Covid-19 vaccine.; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Today was 3rd day of the Paxlovid after tested positive after having been vaccinated and boosted with Moderna Covid-19 vaccine.) in a 47-year-old female patient 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-May-2022, the patient experienced COVID-19 (Today was 3rd day of the Paxlovid after tested positive after having been vaccinated and boosted with Moderna Covid-19 vaccine.). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) on 18-May-2022 for COVID-19, at an unspecified dose and frequency. At the time of the report, COVID-19 (Today was 3rd day of the Paxlovid after tested positive after having been vaccinated and boosted with Moderna Covid-19 vaccine.) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-May-2022, SARS-CoV-2 test: positive (Positive) Positive.         No concomitant medications were reported It was reported that patient had been vaccinated and boosted with Moderna Covid-19 Vaccine. Patient tested positive last Saturday on 14-May-2022. As of 20-May-2022 patient was on 3rd day of the Paxlovid. Unable to clarify what patient tested positive for as call disconnected before inbound transfer complete. Product complaint report was on Moderna Covid-19 Vaccine, not Paxlovid. No treatment drugs were reported  Company comment: This spontaneous case concerns a 47-year-old female patient with no reported medical history who experienced the unexpected non serious AESI of COVID 19 which occurred unknown days after the administration of booster dose of mRNA-1273 vaccine in COVID 19 vaccination series. Patient received NIRMATRELVIR, RITONAVIR (Paxlovid) as treatment for COVID 19. Details about medical history, concomitant medications, other investigations, clinical course and outcome were not provided. The benefit-risk relationship of mRNA-1273 is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 24-May-2022: Follow-up received included product quality complaint number updated.; Sender's Comments: This spontaneous case concerns a 47-year-old female patient with no reported medical history who experienced the unexpected non serious AESI of COVID 19 which occurred unknown days after the administration of booster dose of mRNA-1273 vaccine in COVID 19 vaccination series. Patient received NIRMATRELVIR, RITONAVIR (Paxlovid) as treatment for COVID 19. Details about medical history, concomitant medications, other investigations, clinical course and outcome were not provided. The benefit-risk relationship of mRNA-1273 is not affected by this report.
sore arm; slight flu like symptoms; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old female patient received BNT162b2 (BNT162B2), on 15Nov2021 at 10:00 as dose 3 (booster), single (Lot number: FH8028) at the age of 69 years intramuscular, in arm for covid-19 immunisation. The patient's relevant medical history included: "Hysterectomy", start date: 1978 (unspecified if ongoing); "Illness" (unspecified if ongoing); "B/P" (unspecified if ongoing); "Depression" (unspecified if ongoing); "Cholesterol" (unspecified if ongoing); "Hormone" (unspecified if ongoing). Concomitant medication(s) included: METOPROLOL TARTRATE oral taken for blood pressure abnormal, start date: 2012 (ongoing); CITALOPRAM oral taken for depression, start date: 2019 (ongoing); ESTRADIOL oral taken for hormone therapy, start date: 1999 (ongoing); WELLBUTRIN oral taken for depression, start date: 2012 (ongoing); ATORVASTATIN oral taken for blood cholesterol, start date: 2020 (ongoing). Vaccination history included: BNT162b2 (DOSE 1, SINGLE; Lot number: EN6208; Route of administration: Intramuscular; Anatomical site: upper arm; Vaccine administration time: 9:30), administration date: 16Mar2021, when the patient was 69-year-old, for Covid-19 immunization, reaction(s): "sore arm", "slight flu like symptoms"; BNT162b2 (DOSE 2, SINGLE; Lot number: EW0151; Route of administration: Intramuscular; Anatomical site: upper arm; Vaccine administration time: 10:00), administration date: 06Apr2021, when the patient was 69-year-old, for Covid-19 immunization, reaction(s): "sore arm", "slight flu like symptoms". The following information was reported: INFLUENZA LIKE ILLNESS (non-serious) with onset Nov2021, outcome "recovered" (2021), described as "slight flu like symptoms"; PAIN IN EXTREMITY (non-serious) with onset Nov2021, outcome "recovered" (2021), described as "sore arm".  Additional information: The patient had just sore arm and slight flu like symptoms with first 3 immunizations. Lasted 2 days. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No specific relevant test for thromboembolic events with thrombocytopenia.
Narrative: Patient received first COVID-19vaccine on 1/27/2021 outside of the Facility. Patient reported tiny bumps on both her lower legs along with slight itchiness and erythema four days after vaccination. Patient also noticed similar but larger bumps on her arms which were not itchy. Patient denied tongue swelling, throat closure, fever, chills, flu-like symptoms, cough, SOB, chest pain, and joint pains. Patient was instructed to take loratadine or diphenhydramine as needed for itching. On 2/23/2021, patient reported that skin rash has resolved on its own after lasting for one week.
Hot, red spot surrounding injection site. Not sore. Did not develop until Day 9 after injection. My wife was vaccinated on the same visit with me, and she too developed the hot, red spot at her injection side. A photo of my left arm is here, at the peak of the reaction: https://www.dropbox.com/s/7mm6706bow3cs1p/Jim%20reaction%20to%20Moderna%20vaccine%20day%2010.HEIC?dl=0.
rash on chest and shoulders c/o tightening of throat & S.O.B. Benadryl, Epi per standing orders, then transported to hospital via ems and released later that day.
While Sleeping on Back, sounded as if she was struggling to breathe had white form in mouth, and arms were shaking.  Grandmother held her upright and patted back.  No color change.  Lasted 2-3 min. Squad amued within a few minutes and she was breathing without difficulty.  Seemed sleepy afterward.  At 10:30 am.  She was in my office and was alert and examination was normal.
Mild swelling of R thigh, no erythema, warmness and no signs of infection.
I am having severe Tinnitus. The ringing is so loud that it is interfering with sleep.
High temperature; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PYREXIA (High temperature) in a 91-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (High temperature). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at a dose of 1 dosage form. At the time of the report, PYREXIA (High temperature) outcome was unknown. Not Provided          No concomitant medications were provided. Treatment medications includes Tylenol for fever.
patient received vaccination, then immediately said they felt lightheaded and this always happens when they get injections or blood drawn.  They requested and were given a bottle of water.  They asked to lay down, and laid on the floor for about 10 minutes then said they felt better, sat the remainder of their wait time, then grabbed something to eat in the store, re-established they felt fine now, then proceeded to leave
The Moderna booster (lot# 070H21A) rcvd on 12/27/21 gave left arm, elbow, shoulder pain & weakness. Still today there is mostly elbow pain & weakness. Some left breast/chest pain initially.
Severe chicken pox-like rash covering entire body, some of the rash progressed to pustule-like sores. Severe itching noted with child, mild fever of 100.7 F.
itching in her body, as if a mosquito was biting her in various parts of her body; itch, as if she has an allergy clothing; uncomfortable; little arm pain; chills; blood pressure goes up because she gets nervous; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itching in her body, as if a mosquito was biting her in various parts of her body), PRURITUS (itch, as if she has an allergy clothing), DISCOMFORT (uncomfortable), PAIN IN EXTREMITY (little arm pain) and CHILLS (chills) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20A and 029K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included blood pressure amlodipine, hydrochlorothiazide Diuretic, aspirin per day and ERGOCALCIFEROL, RETINOL PALMITATE (VITAMINS A & D) for an unknown indication.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PRURITUS (itching in her body, as if a mosquito was biting her in various parts of her body), PRURITUS (itch, as if she has an allergy clothing), DISCOMFORT (uncomfortable), PAIN IN EXTREMITY (little arm pain), CHILLS (chills) and HYPERTENSION (blood pressure goes up because she gets nervous). At the time of the report, PRURITUS (itching in her body, as if a mosquito was biting her in various parts of her body), PRURITUS (itch, as if she has an allergy clothing), DISCOMFORT (uncomfortable), PAIN IN EXTREMITY (little arm pain), CHILLS (chills) and HYPERTENSION (blood pressure goes up because she gets nervous) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
This spontaneous report was received from a male patient of unknown age regarding himself. On 27-NOV-2012, the patient was vaccinated with a dose of ZOSTAVAX (Lot #, expiry, dose and route not reported). No concomitant medications were reported. On an unknown date, the patient developed a headache after taking ZOSTAVAX. No treatment information was reported. The outcome of headache was unknown. The relatedness for headache was unknown for ZOSTAVAX. It was unspecified if the patient had sought medical attention. Additional information is not expected.
Inflamed and red in large area; we told pt. to go to MD; MD diagnosed him with cellulitis and prescribed LEVAQUIN.
Vaccinated 10/14 11 AM symptoms started at 8 or 9 pm. C/O constant itching on head (top of head), arms and back of neck, c/o hot flashes lasting 3-4 hrs subsided on its own.
Chills, myalgia, fatigue, headache, nasal congestion, cough
Patient was very nervous prior to injection. Patient received Moderna covid vaccine. Patient was instructed on waiting in the store for a 15 minute observation period. A few minutes later she said her vision was blurry, and then it had passed shortly thereafter and her vision was clear again. She also said she felt tingling in her hands and feet. The pharmacy technician called 911 and the medics arrived and she went to the hospital. The husband had stated he though it was her anxiety.
Fever of 99.1 when normal is 97.1, headache, dizziness, chills, and nausea started 24 hours after shot. Tylenol did not help.
Patient received a undiluted 0.2ml dose, so they received a little less than triple dose. No symptoms at this time.
Extreme swelling,  soreness, pain and heat at injection site. Low grade fever general malaise.
Patient was given Daptacel instead of Adacel. Patient was called 8/31/07 and asked how her arm was and she said he had no problems. I asked how she felt after the injection and she said fine.
warm, h/a, dizzy, nausea, tightness in throat;BP 110/78, P80;
she is unable to get up; This spontaneous case was reported by a consumer and describes the occurrence of DYSSTASIA (she is unable to get up) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Psoriatic arthritis, Immunocompromised and Migraine (low-grade migraine pre-vaccination). Concomitant products included METHOTREXATE and FOLIC ACID for Psoriatic arthritis.   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DYSSTASIA (she is unable to get up). At the time of the report, DYSSTASIA (she is unable to get up) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medications were reported.   This case was linked to MOD-2021-385954 (Patient Link).
On 11/7/2019, the patient called the pharmacy to ask what to do about her arm that has been hurting since getting Shingrix in September. The patient said that the pain was worst during the night when she is trying to sleep and sometimes has difficulty moving arm sometimes. I asked where the pain is located and she said in her muscle between her shoulder and elbow. I asked if she has any pain or soreness in her should and she reported no. She wanted an over the counter recommendation for the pain, I suggested Tylenol or Advil, but since the pain has been ongoing this long I suggested that she visit her primary care doctor.
Information has been received from a nurse concerning a 4 year old patient of unknown gender. Information about concurrent condition, concomitant medication and medical history was not provided. On an unknown date the patient was vaccinated with one dose of VARIVAX lot # N008077, expiry date 09-MAR-2019, subcutaneously for prophylaxis, following temperature excursions of -12.3 Celsius degree for 30 minutes and -9.8 Celsius degree for 3 hours 30 minutes (product storage error). A data logger was involved. No adverse effect was report. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1711USA010721: US-009507513-1711USA010722: US-009507513-1711USA010723: US-009507513-1711USA010724: US-009507513-1711USA010725: US-009507513-1711USA000697: US-009507513-1711USA010727: US-009507513-1711USA010728: US-009507513-1711USA010729: US-009507513-1711USA010730:
The patient was adminstered the Moderna vaccine outside of the EUA, as she is 14 years and 9 months old. Pt has a pediatric nephrologist who will administer dose 2. Her mother has a note form her daughters doctor. The crew that gave her the vaccine did not know to check the age of the patient and she slipped through our screening tools.  Patient had no adverse affects
First shoulder to neck pain radiating to side head. Headache increased every day for 10 days (went to ER) to severe to more than a 10. Tender right top side of head. Extreme excruciating headache.
Patient came in today for flu shot, patient also asked if we were giving covid vaccine booster, I advised pt we were, patient was upset because the call center advised her we weren't giving covid booster vaccines,  I asked patient if she would like to receive covid booster patient advised yes she would like moderna,  I then went to vaccine room and saw that Bilvanet moderna booster open was on shelf, moderna bivalent had sticker placed that states Bivalent moderna, expiration, open date, and initials of opener, i drew booster dosage 0.5, verified lot number and exp, and also had vaccine double verified. Verifier saw bottle with sticker lot number, vaccine was then given to patient, waited 15 minutes after adminstering no allergic reactions, then patient was walked out.
EXPERIENCING MORE ENERGY POST VACCINATION; This spontaneous report received from a patient concerned an adult female. The patient's height, and weight were not reported. The patient's concurrent conditions included pneumonia, and laryngitis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1816022 expiry: 15-AUG-2021) dose was not reported, administered on 05-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-JUL-2021, the subject experienced experiencing more energy post vaccination. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of experiencing more energy post vaccination was not reported. This report was non-serious.
Severe muscle aches, chills, sweats, headache, dizziness, insomnia, brain fog,  painful injection site. All symptoms hit at once, almost exactly 12 hours after injection. Symptoms then last for a few hours before relenting almost exactly 12 hours after they began, though a lingering headache, dizziness, brain fog and insomnia last for another few days.
This case was reported by a pharmacist via call center representative and described the occurrence of rash in a elderly female patient who received Shingrix (batch number BN9L9, expiry date 30th March 2020) for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was recovered/resolved. It was unknown if the reporter considered the rash to be related to Shingrix. Additional details were provided as follows: The age at vaccinationwas not reported. The patient developed a fine and pronounced rash from the elbow to the shoulder after receiving a dose of the Shingrix vaccine.
Patient called today reporting inflamed, red and hot upper arm. I encouraged her to take Tylenol 500mg and ice the injection site as to reduce the inflammation. She is fine otherwise. No pain reported.
Bilateral arm swelling after admin of influenza vaccine and PCV 13, left arm w/ s/s cellulitis.
Shingles diagonsis 2 weeks after second shot, symptoms appeared about 10 days after second shot
The patient failed to mention that he had a previous dose of Johnson & Johnson COVID-19 vaccine earlier in 2021.  He said his doctor told him to go ahead and get the Pfizer or Moderna vaccine since it posed no "contraindications".  Patient has reported NO adverse event to this vaccine combination to date.