chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Dose #1: Moderna/ Dose #2: Moderna/ Dose #3: Pfizer/ Dose #4: Pfizer/ Dose #5: UNKNOWN; COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) and on 08Mar2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 65 years for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 04Jan2021 as dose 1, single (Batch/Lot number: unknown) and on 01Mar2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), on 21Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "osteopenia" (unspecified if ongoing); "arthritis" (unspecified if ongoing); "rosacea" (unspecified if ongoing); "IBS-D" (unspecified if ongoing), notes: IBS-D; "IBS-D" (unspecified if ongoing), notes: IBS-D. There were no concomitant medications. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "Dose #1: Moderna/ Dose #2: Moderna/ Dose #3: Pfizer/ Dose #4: Pfizer/ Dose #5: UNKNOWN"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: just tested positive for covid again 8 days after finishing my Paxlovid dose; (31Jan2023) Positive, notes: just tested positive for covid again 8 days after finishing my Paxlovid dose. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient did not received any Other medication in 2weeks. I just tested positive for covid again 8 days after finishing my Paxlovid dose. Patient had no Known allergies. Paxlovid Treatment for COVID 19 from 19Jan2023 to 23Jan2023.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the events drug ineffective, COVID-19, interchange of vaccine products and the use of suspect product cannot be fully excluded.
coughing up mucus; stuffy nose; lost sense of taste; lost sense of smell; headache; throwing up; The next day was feeling really sick; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (The next day was feeling really sick), PRODUCTIVE COUGH (coughing up mucus), NASAL CONGESTION (stuffy nose), AGEUSIA (lost sense of taste) and ANOSMIA (lost sense of smell) in a 19-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 10-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Aug-2021, the patient experienced MALAISE (The next day was feeling really sick). On an unknown date, the patient experienced PRODUCTIVE COUGH (coughing up mucus), NASAL CONGESTION (stuffy nose), AGEUSIA (lost sense of taste), ANOSMIA (lost sense of smell), HEADACHE (headache) and VOMITING (throwing up). At the time of the report, MALAISE (The next day was feeling really sick), PRODUCTIVE COUGH (coughing up mucus), NASAL CONGESTION (stuffy nose), AGEUSIA (lost sense of taste), ANOSMIA (lost sense of smell), HEADACHE (headache) and VOMITING (throwing up) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not provided.  Treatment information was not provided.
Meningococcal ACWY vaccine; severe rash and hives, itching for days.
January 24, 2018, Summary from Patient: 9/26/2017 flu vaccine left upper arm. Most painful vaccine that I have ever received. Pain continued 2 weeks until it got so severe I needed to see my PCP. 10/16/17. First visit with PCP. Lab work completed to help determine the problem. 10/18/17 follow up with PCP determined that I had valley fever. I had a chest X-ray, was referred to a pulmonologist and started on antifungals. 10/23/17. Pulmonologist did not believe I had valley fever. Repeated labs. Concerned about shoulder pain and recommended MRI. Later that week went to ER and they did Ultrasound to rule out DVT of my Left upper extremity. 10/30/17. Saw PCP she repeated labs and wrote a referral for MRI. 11/3/2017-MRI of left shoulder complete. 11/9/2017-Received results and had more labs ordered due to the fluid noted in the MRI referred to ortho. 11/17/17 referred to hematologist by pulmonologist. 11/17/17 saw ortho determined That the flu vaccine was given into my subscapularis joint. Recommend steroid injection but on hold until I completed hematologist appt. 12/8/17-hemagologist appt complete. 2/2018 scheduled follow-up for left shoulder with ortho for possible steroid injection. Note: The flu shot was actually given on 9/25/17 per consent form.
12-24 hrs post vaccine administered, pt develpoed hives-only on the arm of administration. Pt phoned 11/3/03 hives already gone. C/O dizziness, N&v, and pass fever (did not use thermometer) x 2 days and still a little weak. Reports took Pocadron for hives.
Reportedly about 45 minutes after vaccination, the patient complained of severe pain in the left deltoid radiating to the hand and clavicle. The patient still experiences sporadic pain, especially at night when trying to sleep. The patient was seen in the ER on 10/18, treated and released. On 11/01/2001 seen by family physician who ordered physical therapy for 1 week - no relief. On 11/14/2001 the patient was referred to an orthopedic surgeon. The patient now an appt with a neurologist next week. From additional correspondence received on 02/22/2001, it was reported "neurologist appt cancelled initially due to decreased pain in arm. Approximately the second week of January 2001, numbness and tingling started from the shoulder to the fingertips with occasional pain. Rescheduled appts 02/28/2001. On 03/14/2001 the patient had her appt with the neurologist. The physician also states there is probably muscle reaction to the vaccine itself. The patient continues to have numbness and tingling in the left arm and hand occasionally with occasional pain in the deltoid, as of 03/21/2001.
Patient received the first dose of Moderna vaccine on 4/16/21.  Approximately 6 hours after administration of the vaccine she developed shooting pain in her 5th digit on her left foot. That lasted a couple hours but was resolved when she woke up the next morning. The following night she was having trouble going to sleep as she was tossing and turning and felt like she was having muscle cramps in all her limbs. After this she has continued to have a feeling of fullness and heaviness in her limbs. She has been shooting pains in the bottom of her left foot. She also has the sensation of numbness or burning sensations which can randomly happen anywhere in her body.  She also gets pins and needles in her limbs as well which will lasts for hours.  She also has been having muscle weakness and fatigue more recently. She will feel muscle fatigue on pushing her kids in the swing as well. Based on Neurology evaluation will risk stratify for second dose of Moderna.
severe Glaucoma; This is a spontaneous report received from a Pfizer Sponsored Program. A contactable consumer reported (for herself) a female patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 25Feb2021 (Batch/Lot number was not reported) as SINGLE DOSE for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient received the first dose on 25Feb2021 and due for the second dose by 18Mar2021. The patient stated over the call that that they were experiencing heavy rain and she won't be able to drive to the facility because she has severe Glaucoma (noted in 2021). She wanted to know if she can reschedule the second dose on a later date. Outcome of the event was unknown.   Information on the lot/batch number has been requested.
Narrative: The patient received three doses of Pfizer COVID 19 Vaccine Jan/Feb/Aug 2021. The patient tested positive for COVID 19 on 3 Jan 2022. The patient presented to the ED with cough, fever, and weakness. The patient was admitted with a diagnosis of COVID 19 infection and new onset afib likely secondary to COVID 19. The patient was treated with redesivir and dexamethasone. The patient was discharged on 7 Jan 2022 instable condition.
Arthralgia, Fever, Tachypnea, chills, injection arm pain Narrative:
Felt weak after shot. Several weeks later, felt like I got the flu. Heavy sweating, severe headache (on top of head), back of neck hurt, sensitivity to light and body aches.
Arm started hurting immediately after shot was given. Pain was from shoulder joint down to mid arm. In the daytime, it hurts with physical labor and impedes range of motion. Pain at night wakes him up. Pain has not improved since November, and has gotten worse.
Patient caught covid after first dose; Was due for the the 2nd dose on 10 Feb 2021, it is now a month past the 36-42 days; A spontaneous report was received from a healthcare professional (HCP) concerning a 72-year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273), developed covid 19 and was due for the 2nd dose on 10-Feb-2021, it was now a month past the 36-42 days/(Missed dose).  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 13-Jan-2021, the patient received his first of two planned doses of mRNA-1273 (lot/batch: 037K20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.  On an unknown date, shortly after receiving the first dose, the patient contracted COVID-19.   The patient was hospitalized for six weeks. The patient was due for the second dose on 10-Feb-2021, it was now a month past the 36-42 days.  Treatment information was not reported.  Action taken with mRNA-1273 in response to the events was unknown.   The outcome of the event, COVID-19 was unknown.  The outcome of the event, Missed dose was unknown.; Reporter's Comments: This report refers to a case of Product dose Omission issue for mRNA-1273, with associated AE. Based on the current available information, the mRNA-1723 does not contain a virus capable of causing infection and with the occurrence of Covid-19 infection after vaccination, this event is assessed as unlikely related to mRNA-1273.
Patient was give T-dap booster he didn't need. No symptoms or reaction day of vaccine given.
Patient cries inconsolably for 3 or more nights after receiving her childhood vaccinations. It has worsened after each round. This happens 3-5 days after immunizations, and lasts for 3-5 hours every night.
As per the patient about two days after receiving the first dose of Moderna Covid-19 dose, she experienced pain on the left side of the head and also the left arm . After that day  she has severe Vertigo and it did not go away as of 04/19/2021.
Pain all over the body; feeling really sick; Feel tired; terrible shattering chills; pain on the head, like stabbing pain; very high fever 102°F; turned out negative; This spontaneous case was reported by a consumer and describes the occurrence of ANTIBODY TEST NEGATIVE (turned out negative), PAIN (Pain all over the body), MALAISE (feeling really sick), FATIGUE (Feel tired) and CHILLS (terrible shattering chills) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025J20A and 025J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Medical history was not provided.  Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), ATENOLOL and VITAMINS NOS for an unknown indication.   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On 08-Feb-2021, the patient experienced ANTIBODY TEST NEGATIVE (turned out negative). On an unknown date, the patient experienced PAIN (Pain all over the body), MALAISE (feeling really sick), FATIGUE (Feel tired), CHILLS (terrible shattering chills), HEADACHE (pain on the head, like stabbing pain) and PYREXIA (very high fever 102°F). At the time of the report, ANTIBODY TEST NEGATIVE (turned out negative), PAIN (Pain all over the body), MALAISE (feeling really sick), FATIGUE (Feel tired), CHILLS (terrible shattering chills) and HEADACHE (pain on the head, like stabbing pain) outcome was unknown and PYREXIA (very high fever 102°F) had resolved.            Treatment medication not reported.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Very limited information regarding this event (antibody test negative) has been provided at this time.   This case was linked to US-MODERNATX, INC.-MOD-2021-014817 (E2B Linked Report). This case was linked to MOD-2021-014817 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Very limited information regarding this event (antibody test negative) has been provided at this time. US-MODERNATX, INC.-MOD-2021-014817:
INTUSSUSCEPTION, BOWEL PERFPRATION  5/25/07 Received hospital medical records which reveal patient experienced bloody stools x 4 days prior to admit 3/22/07-4/6/07. Patient to OR after bowel perforation for exp lap  & colostomy was done.  ID consult done & started on multiple IV antibiotics.  Initially vented but able to extubate quickly.  To cath lab on 3/29 for dilation of coarctation.  Transfused for low H/H.  Tolerated oral feedings as well as NGT feedings.  GI consult revealed GERD & delayed gastric emptying.  Progressed well & was d/c to home w/close f/u by multiple specialties. FINAL DX: Intussception; bowel perforation secondary to BE; exp lap & colostomy.
This spontaneous case, reported by other healthcare professional and initially received on 06-Jun-2018, concerns a 11-month old infant, male patient. The patient had no medical history and concomitant medications were not reported. However, it was reported that, the patient eats eggs and does not have any reaction. On 30-Oct-2017, the patient was administered with influenza vaccine (dose, route of administration, anatomical location, batch number, expiry date, trade name and manufacturer: not reported). The patient also received non-company suspect Hepatitis A vaccine (dose, route of administration, anatomical location, batch number were not reported), Varicella zoster vaccine (dose, route of administration, anatomical location, batch number were not reported) and Measles vaccine, mumps vaccine, rubella vaccine (dose, route of administration, anatomical location, batch number: not reported). On the same day, within two hours after vaccination, the patient experienced diarrhoea which lasted for a week. The outcome of the event (diarrhoea) was not reported. Update 22-Jul-2018: Case correction was performed 06-Jun-2018: The causality of the event 'diarrhoea' was corrected from related to unassessable. The case comment was amended accordingly.
pain and soreness in her back and shoulder,; pain and soreness in her back and shoulder,; pain, the regular soreness; she was feeling the armpit pain; swollen arm/whole right arm and hand swollen; armpit is painful and swollen; This is a spontaneous report from a Pfizer sponsored program . A contactable consumer (patient) reported that a 21-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EW0183), via an unspecified route of administration in right arm on 29Jun2021 at 08:17 (at the age of 21 years old) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient not had history of previous immunization with the Pfizer vaccine considered as suspect. No family medical history relevant to adverse events was provided and no relevant tests were performed. The patient did not receive additional vaccines on same date of the Pfizer suspect. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. She had initial onset of side effects on 30Jun2021 starting with pain, the regular soreness; then she was feeling the armpit pain and then slowly during the day started feeling the back pain; she is having back pain and her whole right arm and hand are swollen. She is not sure about the back pain; she can't sleep on her right arm because of having the vaccine shot and usually she sleeps on that side; so it could be that being tensed up from not sleeping on the right side could have caused the back pain. The armpit pain and swelling of right arm and hand she is not sure about. She is experiencing swollen arm, armpit is painful and swollen, pain and soreness in her back and shoulder, whole right arm and hand swollen. She asked for further information about these side effects. She specified outcome of side effects as persistent. The patient did not visit emergency room or physician office. Treatment received: Tylenol 500mg every 6 hours after the vaccine for the soreness; they told her to take it so she did and it helped the pain come down a little bit. Tylenol: Lot: SMA034, Expiry: Aug2022, UPC: Unknown, but . The outcome of events was not recovered.
This spontaneous report as received from a medical assistant refers to a patient of unknown age. The patient's medical history and concurrent conditions were not reported. On 09-JUL-2016, the patient was vaccinated with expired dose of M-M-R II (lot # K005431, expiry date: 15-APR-2016) (route of administration: subcutaneous) (expired vaccine used). No adverse effects reported. The outcome of the events was unknown. Additional information had been requested.
Very Bad Chills; Fever; Fatigue; Nausea; Headache; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 05-Mar-2021 and was forwarded to Moderna on 05-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Nausea), HEADACHE (Headache), CHILLS (Very Bad Chills), PYREXIA (Fever) and FATIGUE (Fatigue) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027821A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced NAUSEA (Nausea) and HEADACHE (Headache). On 03-Mar-2021, the patient experienced CHILLS (Very Bad Chills), PYREXIA (Fever) and FATIGUE (Fatigue). At the time of the report, NAUSEA (Nausea), HEADACHE (Headache), CHILLS (Very Bad Chills), PYREXIA (Fever) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
No adverse event; the patient was administered the first dose at age 5 months old; This spontaneous report as received from a medical assistant refers to a 5 month old patient of an unknown gender and Race. The patient's concurrent conditions, medical history and concomitant medications were not reported.      On 07-MAY-2020, the 5 month old patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # S017642 has been verified to be a valid lot number, expiration date reported 20-FEB-2021, but upon internal validation established as 28-FEB-2021), for prophylaxis (dose and route of administration were not reported) (product administered to patient of inappropriate age).
Information has been received from a Certified Registered Nurse Practitioner (C.R.N.P.) concerning a patient who declined the first dose of GARDASIL (lot # unknown) because she said, she had a friend who had received a dose of GARDASIL and had fainted and then ended up with a seizure disorder. The actual patient did not proceed with getting the shot out of fear, however this adverse event was recorder according to the patient's friend who was an anonymous individual. Upon internal review, seizure was considered to be other important medical event. This is a hearsay report in the absence of an identifiable patient. Attempts are being made to verify the existence of a patient. Additional information has been requested.
25SEP97 pt recv vax left to classroom 10min later returned feeling sl SOB & had rash on neck & chest & back & upper arms;rash appeared to look like hives;BP 126/70;given adrenalin;rash & sx dec & p/about 15min rash gone;
Patient developed fever of 102 degrees F the day after vaccine administration. Also developed runny nose, ear pulling, trouble eating and sleeping, and brownish rash on right leg, upper back, and face. The fever continued for 4 days and then developed a rash all over the body.
early second dose; Shingrix vaccine instead of a flu vaccine; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 62-year-old female patient who received Herpes zoster (Shingrix) (batch number 57LJM, expiry date 14th April 2023) for prophylaxis.   Concomitant products included RECOMBINANT VARICELLA ZOSTER VIRUS SURFACE GLYCOPROTEIN E (SHINGRIX).   On 24th October 2021, the patient received the 2nd dose of Shingrix. On 24th October 2021, unknown after receiving Shingrix, the patient experienced drug dose administration interval too short and wrong vaccine administered. On an unknown date, the outcome of the drug dose administration interval too short and wrong vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The pharmacist reported that the patient received 1st dose of Shingrix vaccine on 1st October 2021 and 2nd dose of the Shingrix vaccine instead of a flu vaccine on 24th October 2021, which led to drug dose administration interval too short and wrong vaccine administered. No further information reported. The reporter consented to follow-up by email.
Patients arm became extremely sore and swollen the day after vaccination; cannot lift arm; has to wake up multiple times a night to take tylenol for pain; injection into rotator cuff???? patient is seeing her PCP on Tuesday