chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Tested positive for Covid; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Tested positive for Covid) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2022, the patient experienced COVID-19 (Tested positive for Covid). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19, at an unspecified dose and frequency. At the time of the report, COVID-19 (Tested positive for Covid) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2022, SARS-CoV-2 test: (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient had fourth booster of Pfizer COVID-19 vaccine (lot numberFJ4991.) on 19 Jul 2022.(route - intramuscular). Patient was taking more concomitant prescription medications, but nothing relevant to COVID. Patient had COVID-19 following family funeral and treated with Paxlovid (Miracle drug).   Most recent FOLLOW-UP information incorporated above includes: On 18-Oct-2022: Follow-up received include. Patient Demographics (D.O.B. ,age, height, weight) added, Product details updated, Narrative updated
No adverse effects; that patient received first dose of Hepatitis A vaccine (unspecified name and manufacturer) in 2011 and second dose of Hepatitis A vaccine in 2017; This spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. The patient's historical condition, concomitant medications and drug reactions or allergies were not reported.          On an unspecified date in 2011, the patient received the first dose of hepatitis a vaccine, inactivated (manufacture unknown) (dosage schedule, route, anatomical location, lot number and expiration date were not reported).   On an unknown date in 2017, the patient received the second dose of hepatitis a vaccine, inactivated (manufacture unknown) (inappropriate schedule of product administration) (dosage schedule, route, anatomical location, lot number and expiration date were not reported). No adverse effects reported.    The outcome of inappropriate schedule of product administration was unknown.
Received immunization on 2/9/03 8am. At 7pm on 2/9/03 complained of tenderness in arm, achy feeling all over. Took Tylenol. Presents on 2/10/03 15x10mm local redness. Complained of diarrhea today, dry mouth. Temp 98F, BP 110/78, P 60.
Near death experience; she can no longer work; This case was reported by a consumer via interactive digital media and described the occurrence of near death experience in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced near death experience (serious criteria GSK medically significant and life threatening) and inability to work. On an unknown date, the outcome of the near death experience was not recovered/not resolved and the outcome of the inability to work was unknown.   It was unknown if the reporter considered the near death experience and inability to work to be related to Shingles vaccine.  Additional details were provided as follows: The patient was the reporter's cousin. The age at vaccination was not reported. The reporter stated that the patient nearly died when she had a Shingles vaccine and it happened, initially and every month since, she had nearly died and would for the rest of her life. The reporter stated that the patient needed to get medical treatments, that was financially impossible for her to pay for and she could no longer work. The follow-up would not possible as no contact details were available.
Patient was scheduled to receive DTaP.  Staff member assigned to give accidentally grabbed vaccine from adjacent box, that was Hepatitis B, which was then administered to patient. This was discovered on 3/1/2023, as vaccines were being inventoried.
throat swelling; Initially had headache; dizziness; irritability; Throat tingling; difficulty swallowing; This is a spontaneous report from a contactable other healthcare professional (HCP) (patient). A 49-year-old female patient received a single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot#: EJ1685) as the first dose via an unspecified route of administration in the left arm on 29Dec2020 06:00 for COVID-19 immunization. Medical history included fibromyalgia, asthma, prediabetes, and carpal tunnel syndrome. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There were not any other medications the patient received within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. The patient had no previous allergies to vaccines. The patient allergies to medications which included: doxycycline, medroxyprogesterone acetate (DEPO-PROVERA), metoclopramide (REGLAN), gluten. The patient initially had headache, dizziness and irritability, throat tingling, throat swelling, and difficulty swallowing started around 12 hours after injection, event onset date reported as 29Dec2020 18:00. The events resulted in emergency room/ department or urgent care. The events were reported as non-serious by HCP. Treatment received for the events included diphenhydramine and hydroxyzine embonate (HYDROXYZINE PAMOATE). The outcome of the events was recovering.; Sender's Comments: The reported pharyngeal swelling together with other symptoms was likely related to the single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) due to temporal relationship.  The case will be reassessed should additional information become available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.
Pt. in clinic for Immunization update on 7/16/13, receive Tdap and MCV, 0.5 ml, IM, (R) deltoid given. Pt waited in lobby for 20 mins on 7/16/13 w/o any s/s of adverse reactions. Pt and mother returned to clinic on 7/18/13 w/ c/o site pain. Pt. was checked in to clinic for PCM evaluation of site. PCM noted site redness, warm to touch, 7cm to 9cm area noted on (R) deltoid site. Pt's mother was advised to continue to use cool compresses, MOTRIN 600mg, PO, every 6 hrs w/ food per PCM order.
Two weeks after the vaccine I got my Menstrual Cycle about 10 days late. The next one was 20 days early.  They were about the same length as usual, but they were very heavy. I was passing a lot of blood clots. It has been six months and the timing has been more normal, but the blood flow is still much heavier. I normally have a very regular cycle and the clotting is very unusual.
This case was reported by a consumer via call center representative and described the occurrence of numbness of limbs in a 14-year-old female patient who received FLUARIX QUADRIVALENT (batch number 375RS, expiry date 30th June 2014). On 20th November 2013, the patient received FLUARIX QUADRIVALENT. On 20th November 2013, immediately after receiving FLUARIX QUADRIVALENT, the patient experienced numbness of limbs. On 20th November 2013, the outcome of the numbness of limbs was recovered/resolved. It was unknown if the reporter considered the numbness of limbs to be related to FLUARIX QUADRIVALENT. Additional details were provided as follows: The mother of the patient was the reporter. The patient received FLUARIX QUADRIVALENT in the left arm and felt numbness in the arm. The patient was told to sit down at the doctor's office and was monitored. The event resolved and the patient was sent home. No other events were noted. The patient has denied permission to contact their physician.
- Pain and swelling of left armpit x 5 days (received the Moderna COVID-19 vaccination on 1/5/2021).   No airway or ocular involvement; No acute anaphylaxis; No acute infection or lymphangitic streaking appreciated. Supportive measures were advised. May take counter Tylenol or Motrin, as needed, for pain relief.  Continue to monitor symptoms.  Monitor for signs and symptoms of secondary infection. - Patient also reported, on the evening of 1/5/2021, after receiving the vaccination, experienced acute chills and fatigue ? resolved by 16/2021.
Lethargic, pale, glassy and pinpoint eyes to unresponsive, limp and falling to the right side. Client laid on ground due to unresponsiveness and unable to obtain vitals, client gasped when laid flat then  reported nausea, rolled to side client started vomiting. EMS called, EKG ran, client refused services. Walked out of clinic.
No adverse event Covid 19 vaccine expired 10/27/2022 Given 11-07-2022
tongue swelling; fingers cramping up; flu like symptoms; white dot big as dime solid white; swelling in her arm; arm  red; pain all the way down to arm; A spontaneous report was received from a consumer concerning a 62-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced tongue swelling,  white dot big as dime solid white (papule), fingers cramping up (muscle spasms), flu like symptoms, vaccination site swelling, vaccination site erythema and  vaccination site pain.  The patient's medical history was not provided. Concomitant medications reported were levothyroxine, lisinopril , premarin 0.625, omeprazole, valacyclovir, d-amphetamine salt.  On 05-Mar-2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 027A21A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced swelling in her arm, . arm red, white dot big as dime solid white, tongue swelling, pain all the way down to arm , fingers cramping up, flu like symptoms.  On 07-Mar-2021 the patient reported to the hospital, was evaluated by a physician who took blood and advised her to go home and take diphenhydramine. Treatment details included tylenol and benadryl.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events, tongue swelling,white dot big as dime solid white,fingers cramping up, flu like symptoms, vaccination site swelling, vaccination site erythema and vaccination site pain, was considered recovered/resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a male patient who received Shingrix for prophylaxis. On 13th September 2018, the patient received the 1st dose of Shingrix. On 13th September 2018, less than a day after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown. It was unknown if the reporter considered the pain in arm to be related to Shingrix. Additional details were received as follows: This case was previously not reported to anyone. The age at vaccination was not reported. On the date of reporting, the patient received a dose of Shingrix and experienced arm pain. The patient hung up the call before providing any demographics or other information.
Information has been received from a pharmacist concerning a 66 year old male with a history of knee replacement 2 months ago who on 14-OCT-2008 was vaccinated with PNEUMOVAX, 0.5ml, very far up near left shoulder joint. On 14-OCT-2008 8PM the patient went to urgent care treatment center with complaints of pain and his shoulder locking up; and decrease mobility. The patient was treated with prednisone and KEFLEX, and was released. The patient was not hospitalized. Pharmacist states the patient was recovering from knee surgery so the patient took some OXYCONTIN but it did not relieve the pain in his shoulder. The patient's pain and his shoulder locking up; and decrease mobility persisted. Additional information has been requested.
Age not checked at time of vaccination; This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Age not checked at time of vaccination) in a 16-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-2021 at 9:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Age not checked at time of vaccination). On 12-Feb-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Age not checked at time of vaccination) had resolved. 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.   No concomitant and treatment medication was reported   Most recent FOLLOW-UP information incorporated above includes: On 17-Jun-2021: patient demographics, vaccine  information such as batch number anatomical location was updated.
Information has been received from a physician concerning a 17 year old female who on 13-AUG-2007 was vaccinated IM with 0.5mL Gardasil (lot # 657006/0188U). Concomitant therapy included tetanus toxoid vaccine. On 15-AUG-2007 the patient developed a severe headache and went to the emergency room. She underwent a head CT scan which was normal and a lumbar puncture which was positive for aseptic meningitis. She was diagnosed with aseptic meningitis. Her treatment was unknown. She was not hospitalized and had since recovered. The physician considered aseptic meningitis to be an other important medical event. Additional information has been requested.
Diffuse body and joint aches, pleuritic chest pain, malaise, insomnia due to pain- started ~12 hrs after vaccine and got worse over next 1-1/2 days then plateaued. Body aches and chest pain lessened 3rd day but rheumatoid arthritis flared up in hands and feet especially on 4th day
Patient's mom called reporting that patient lost her voice after receiving her second Moderna vaccine on Saturday. She called on Monday. (2 days later). I will follow up with her tomorrow but told her to contact PCP if not better in next one to two days.
This spontaneous report was received from a Registered Medical Assistant concerning a 63 year old female patient with hypercholesterolemia and hypertension and no drug reactions/allergies. On 05-NOV-2013, the patient was vaccinated with a dose of ZOSTAVAX (lot # J004267; expiration date 12-JUL-2014), 0.5 ml, subcutaneous in the left deltoid. Concomitant therapies included Crestor and Clinoril. It was reported that a patient who received ZOSTAVAX contacted her practice to report that she began to develop a rash on her back. On 13-NOV-2013, the patient was examined by another physician, since the primary physician was not in the office, who diagnosed the patient's rash as a shingles-like vesicular rash. The physician prescribed Valacyclovir 1 gram three times a day for seven days for the patient. The reported did not know if the patient had fully recovered. The patient did not report any discomfort. No laboratory tests were performed. Patient's outcome was reported as recovering/resolving. Additional information has been requested.
8/9/02 TC from pt's mother. Child had hoarsenes 2 hrs after vaccines given 8/12/02. TC to pt's mother. Child still hoarse MD ordered antihistamine and diagnosed allergies not vaccine related.
seizures; small stroke; A spontaneous report was received from a consumer (wife of patient) concerning a 78- year-old, male patient who  developed seizure and a small stroke.    The patient's medical history included seizure 4 years ago, stroke long time ago. Products known to have been used by the patient, within two weeks prior to the event, Cholesterol medicines, Blood pressure medicines and Aspirin.  On 18 Feb 2021, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (Lot 031M20A) intramuscularly in the Right arm for prophylaxis of COVID-19 infection.   On 18 Feb 2021, the patient developed seizure, small stroke .  Treatment for the event was not reported. Doctors are not sure about the causality, but want to report it. They spoke to his doctor  about not getting the second vaccine.    Action taken with mRNA-1273 in response to the event was unknown.  The outcome of the event's, seizure, stroke was considered unknown.; Reporter's Comments: The events were consistent with increased risk of complications associated with history of seizure confounded by elderly age of patient. Company assessed the events to be unlikely related to company product.
MMR given at 11:20 on 4/27/01; at 12:15, started with tight cough, difficulty breathing, audible wheezing and decreased breath sounds. Taken to ER and stabilized. Transferred to adult ER.
Swollen right axillary lymph node. Pruritus of the abdomen and thorax as well as both arms. No difficulties with breathing nor visibile rash are present.
Sore Arm; Sore Throat/Scratchy Throat; Sore Throat/Scratchy Throat; Headache; Chills; This is a spontaneous report received from a contactable consumer (Patient) reported for himself. A 48-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EK5730 and expiration date was not provided) and (lot number: EK5730 and expiration date was not provided), via an unspecified route of administration, in Arm left, on 25Mar2021 at 01:30 PM (at the age of 48-years-old) at a single dose for COVID-19 immunisation, at workplace clinic. Medical history and concomitant medications were not reported. Allergies to medications, food, or other products included: gluten, penicillin, ciprofloxacin, differin, tessalon pearls. The patient previously took first dose of BNT162B2 (lot number: EJ1685) on 04Mar2021 at 03:30 PM (at the age of 48-years-old) in Left arm for COVID-19 immunisation and experienced headache /sore arm started after first dose, headache started within 1 hour of receiving vaccine. Patient did not receive other vaccine in four weeks of vaccination. Patient did not receive other medications in two weeks of vaccination. Patient was not diagnosed with COVID, prior vaccination. Patient has not been tested for COVID, post vaccination. It was reported that on 26Mar2021 at 01:00, the symptoms started after receiving second dose at around 1 am after 2nd dose, dose time was 1:30 pm day before sore arm sore throat/scratchy throat, headache, chills. The events were reported as non-serious. No treatment was received for the events. Outcome of the events was not recovered.  No follow-up attempts are needed. No further information is expected.
Presented to ED with weakness, SOB, fever, cough; + covid ED CXR:  Reticular densities greater on the left concerning for elements of  pulmonary interstitial fibrosis.; DX Covid PNA  Labs: D-dmer: 1.12; CRP 13.03; Ferritin 2002; TX: Rocephin, Decadron, Remdesivir, Lovenox, Zinc; remained on FiO2 via NC during stay; discharged on 5LPM NC
I had a low-grade fever of 100.4 and chills and a cough. I was tired.  The fever was gone in two days.
Approximately 45 minutes after vaccination felt sensation of mouth becoming completely dry, felt as though regular swallowing process interrupted. Had a glass of water and resolved. Evaluated by doctor and had pulse of 92 (high for patient) and elevated blood pressure 148/92. Rest of vitals normal. Felt anxious. Ate lunch, had about 6 more episodes of mouth drying out, last one about 10 hours after vaccine.  Resolved with water. Took benedryl 50mg. Next felt fatigue and right arm soreness. Felt normal within 48 hours.
Information has been received from a physician concerning a male junior high school student who about six months ago, in approximately March 2007, was vaccinated with 0.5 ml, booster shot, of varicella virus vaccine live (Oka/Merck). On an undisclosed date the patient developed shingles. At the time of reporting the patient was recovered. Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested.
10:30 am on 12/19/2020  Fever of 100.6 F, malaise, nausea, muscle aches, increase HR to 111 at rest. Tylenol 500mg taken
Immediate pain followed later by decreased strength and movement of arm.  A third dose of MMR had been mistakenly administered.
I experienced a little facial numbness after both vaccines which was on going for a period of time after the vaccine. On 9/9 my nose began running, body ached really bad and I was severely weak. The weakness was so bad I could barely get out of bed and I developed chills also. Frequent restroom visits, but no fever developed so on 9/10 I took a COVID test and it was positive. To date I still get really tired easily and I get bouts of SOB periodically throughout the day resulting in me having to go outside and take deep breaths just to get some relief.
*********************COVID BREAK THROUGH CASE******************** I started about April 24 I was very fatigue then aches and pain and sore throat chills and fever. Then it was just extreme fatigue weak and tired slept a lot. This lasted for about 4 days. Then I had like a cold type thing and then about 7 days i started improving then it all went away I think I developed it on a trip in the plane. I texted my doctor through the app and she told me I was pretty healthy and didn't need Paxlovid at the moment.
fever of 101 for 6 hours  severe headache for 12 hours severe body aches for 24 hours