chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous non-valid report was received from a registered nurse and refers to three unspecified patients. No information about the patients' pertinent medical history, concomitant medications, drug reactions, or allergies was provided. On an unknown dates, one unspecified patient was vaccinated with a dose of PNEUMOVAX 23 lot # N030111, expiration date 21-APR-2019 (dose, route of administration were not reported) and two unspecified patients were vaccinated with a dose of ROTATEQ given orally, lot # N013393, expiration date 11-DEC-2018 and lot #N021308, expiration date 05-MAR-2019 (dose was not reported). Temperature excursion was from 0 degrees Celsius to 1 degrees Celsius (0.4 C) for 30 minutes. Previous temperature excursion was from 0 degrees Celsius to 1 degrees Celsius (0.9 C) for 40 minutes. The information was obtained from the data logger. No adverse effects were reported in any of the patients. Lot Number N021308 is valid for ROTATEQ. As of 06-SEP-2018, all telephone attempts to obtain follow-up information had been unsuccessful. Additional information has been requested. Follow up information was received from the registered nurse on 10-SEP-2018. This spontaneous report concerns a 10 week old patient of unknown gender. Information on patient's pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On 13-FEB-2018, the patient was vaccinated with a dose of improperly stored ROTATEQ (lot # N013393 and expiration date: 11-DEC-2018), (strength and dose were not reported) orally for prophylaxis. It was reported that the vaccine was stored between 0 degrees Celsius to 1 degrees Celsius (0.4 C) for 30 minutes. Previous cold temperature excursion (09-FEB-2018) was from 0 degrees Celsius to 1 degrees Celsius (0.9 C) for 40 minutes. The digital data logger was involved in recording the temperature excursion. No adverse effects were reported. There was no product quality complaint (PQC) reported. This is one of the many reports from the same source. Sender's Comments: US-009507513-1809USA008677: US-009507513-1809USA008678: US-009507513-1809USA008679: US-009507513-1809USA008676.
DEVELOPED RASH 24 HOURS AFTER PFIZER BOOSTER, REDNESS FROM INJECTION SITE TRAVELING DOWN TO ELBOW AND TURNING INWARD.
Injection site swelling; Injection site redness; Fever; Injection site soreness; This case was reported by a consumer and described the occurrence of injection site swelling in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site swelling (received 1st dose on an unknown date, refer case US2019AMR134670).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site swelling, injection site erythema, fever and injection site pain. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site swelling, injection site erythema, fever and injection site pain were unknown.   It was unknown if the reporter considered the injection site swelling, injection site erythema, fever and injection site pain to be related to Shingrix.  Additional details were provided as follows: The case was reported by the GlaxoSmithKline employee on behalf of her aunt. The age at vaccination was not reported. It was reported that when the patient got the Shingrix vaccine she had the injection site swell and turn red for several days after the shot. The patient also ran a fever and the injection site was sore to the touch for a number of days afterwards. The patient said that none of her friends who also got the vaccine had the same reaction. She said they were both listed as side effects (unknown which two events) from the shots so she was not sure if she needed to report it or not so erred on the side of caution and reported the incident.
Shot was done in the shoulder of left arm - pain is in the armpit and side of left breast, very achey; Shot was done in the shoulder of left arm - pain is in the armpit and side of left breast, very achey; This is a spontaneous report from a non-contactable consumer (patient). A 36-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: Unknown), via an unspecified route of administration in the left arm on 07Feb2021 (at the age of 36-year-old) as single dose for COVID-19 immunisation. Medical history included anxiety from an unknown date and unknown if ongoing. The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included unspecified antibiotic, unspecified steroid, ibuprofen, loratadine (CLARITIN); taken all for an unspecified indication, start and stop date were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 07Feb2021, the patient stated that shot was done in the shoulder of left arm and pain was in the armpit and side of left breast, very ache. The patient did not receive any treatment for the events. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was reported as not resolved.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 33-year-old male patient received BNT162b2 (BNT162B2), on 23Dec2021 as dose 3 (booster), single (Lot number: FL3197) at the age of 32 years for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 12Jan2021 as dose 1, single (Lot number: 027L20A) and on 09Feb2021 as dose 2, single (Lot number: 016M20A) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 09Aug2022, 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: indication: Treatment of COVID-19; (09Aug2022) positive, notes: I tested positive for COVID on 09Aug; (17Aug2022) Negative, notes: continued to show improvement and tested negative from 17Aug-20Aug; (18Aug2022) Negative, notes: continued to show improvement and tested negative from 17Aug-20Aug; (19Aug2022) Negative, notes: continued to show improvement and tested negative from 17Aug-20Aug; (20Aug2022) Negative, notes: continued to show improvement and tested negative from 17Aug-20Aug; (22Aug2022) positive, notes: I got tested on 22Aug and subsequently resulted as COVID positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Known allergies: No. patinet tested positive for COVID on 09Aug2022. He started taking Paxlovid on 10Aug2022 and finished the series on 14Aug2022. He continued to show improvement and tested negative from 17Aug2022-20Aug2022. On 21Aug2022, he woke up with COVID symptoms. He got tested on 22Aug2022 and subsequently resulted as COVID positive.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events Drug Ineffective and Covid-19 and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
Swelling, redness, pain, itching/burning. Treatment TYLENOL PRN, NSAIDS PRN BENADRYL 35mg QHS PRN 3-5 days.
This spontaneous report was received from a registered nurse referring to an infant patient of unknown age and gender. The patient's medical history, concurrent conditions ans concomitant therapies were not reported. On 12-JUN-2018, in the same office visit, the patient was inadvertently administered with PROQUAD (lot # N029672 with expiration date of 21-APR-2019; strength, dose, route and anatomical location were not provided), for prophylaxis; VARIVAX (lot # N032744 with expiration date of 20-NOV-2019; strength, dose, route and anatomical location were not reported), also for prophylaxis; and sterile diluent (manufacturer unknown) (strength, dose, route, lot #, expiration date and indication were not provided). No adverse effects reported.
The adverse event was a patient was giving second dose 1 day early on day 16.  No adverse reactions were observed or reported by patient.
Vaccine given to patient at 10:30am 4/14/21 and he called main office and left message that evening on nurse voicemail that he had symptoms starting at 4pm- Severe headache, chest pain, SOB, vomiting and diarrhea. Nurse practitioner called him back the next day when returned to office and retrieved messages and called patient back.  He reported he has hx of Cardiac and lung problems and that he had a bad reaction to his flu shot when had in past.  He replied no to all these questions on the questionaire, and when asked by staff giving the shot. He was advised by Nurse practitioner to go to ER
Felt bad, blah, for 12 hours.; malaise, for 12 hours.; Soreness at injection site, 12 hours.; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Felt bad, blah, for 12 hours.), MALAISE (malaise, for 12 hours.) and VACCINATION SITE PAIN (Soreness at injection site, 12 hours.) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004C21A, 002A21A and 032M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 17-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, the patient experienced FEELING ABNORMAL (Felt bad, blah, for 12 hours.), MALAISE (malaise, for 12 hours.) and VACCINATION SITE PAIN (Soreness at injection site, 12 hours.). At the time of the report, FEELING ABNORMAL (Felt bad, blah, for 12 hours.), MALAISE (malaise, for 12 hours.) and VACCINATION SITE PAIN (Soreness at injection site, 12 hours.) had resolved.      No concomitant medication information provided. It was reported that patient was calling because she received a form from safety but didn't want anyone thinking that she had serious problems. She knows that if she had taken some Tylenol, symptoms would had been relived, she just didn't want anything hindering the efficacy of the vaccine. It was reported that patient took first booster dose No treatment information provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-651643 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-651643:same reporter
miscarriage; This is a spontaneous report from a contactable consumer (patient). This consumer reported information for both mother and fetus. This is the maternal report.  A 34-year-old female patient received second dose of bnt162b2 (BNT162B2), via an unspecified route of administration, administered in left arm on 06Oct2021 18:45 (Batch/Lot Number: FF8839) as dose 2, single for covid-19 immunisation. Patient received first dose of BNT162B2 on 24Aug2021 12:45 PM in left arm with lot number FC3183. No other vaccine in four weeks. None other medications in two weeks. None medical history. No Covid prior vaccination. Patient last menstrual date: 02Aug2021. Patient received a positive pregnancy test about two weeks after first vaccine at about 6 weeks pregnant. At an ultrasound at 8 weeks 4 days the baby was measuring small (about 7 weeks) and had a lower heart rate. At an ultrasound at 10 weeks the baby measured 7 weeks and 1 day with no heartbeat, resulting in a miscarriage. The event resulted in: healthcare professional office/clinic visit, Congenital anomaly or birth defect, and received treatment. NO covid tested post vaccination. The outcome of miscarriage was recovering as reported.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101551947 Same reporter/drug, different patient and event (fetus case).
Fever of 104, immense excruciating neck pain, arm has welt on it, and is in large amount of pain.
¨Pain arm that lasted for a while after the 1st dose¨; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (¨Pain arm that lasted for a while after the 1st dose¨) in a 37-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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (¨Pain arm that lasted for a while after the 1st dose¨). At the time of the report, PAIN IN EXTREMITY (¨Pain arm that lasted for a while after the 1st dose¨) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was provided  Treatment medication was not provided for dose 1
pt recvd vax 25FEB95 & 28FEB95 devel peripheral sensory neuropathy w/marked demyelination shown on EMG:dx w/GBS & was hospitalized in ICU;
Client came in to report unusual rashes for which she could find no cause. On Feb. 15th, client developed a red, streaky rash over right arm only. Client has pictures on her phone. The rash was red, streaky across arm's length, itchy and raised. Client states she took BENADRYL and applied cortisone cream to affected areas. Client states the rash resolved in 24hrs so she did not seek medical intervention. The same type of rash occured on March 11th to the right arm again. Exactly the same in appearance with client applying the same treatment (BENADRYL and cortisone cream) and the rash resolved in 24 hrs. On March 20th, the same type of rash appeared on the left arm, Client applied the same treatment and it resolved in 24 hrs. Client states that because she was not ill and the rashes resolved themselves within 24 hrs she did not seek nedical intervention. However, she did think the unusual nature of the rashes, the streakiness and onesidedness, reminded her of shingles so she felt it was worth reporting the incidents to our Health office, where she received the vaccines.
Symptoms began within 24 hours after Janssen vaccine (1 of 1): extreme weakness (lethargy), diarrhea, low energy, no appetite, chills/sweats (no fever),  some loss of hair (minimal but noticeable), overall malaise, inability to focus/concentrate.  Symptoms continue and are ongoing (8+ days).   Telemedicine appt on  04/07/21 Labs ordered for 04/09/21
emesis x1 after influenza immunization.  No other signs of anaphylaxis and did well w/o intervention.  Allergist tested and found that she was allergic to influenza skin prick test and considered this event as mild anaphylaxis.
Pain at injection site, swelling, erythema, axillary lymphadenitis, fever, chills, malaise, headache
Headache, Sedation, Fever, NauseaVomiting, Swollen lymph nodes, Pain @ injection site Narrative:
This spontaneous report as received from a certified medical assistant refers to an unspecified number of patients of unknown age and gender. Concurrent conditions and medical history were not reported. On an unknown date, the patients were with vaccinated doses of ROTATEQ (lot # reported as L000568, expiration date 10-JUL-2016, lot # K020182, expiration date 25-JUN-2016) (oral, dose was not reported), which had a temperature excursion. Concomitant medications were not reported. No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
PT RECIEVED 3RD ANTHRAX VACCINE 09FEB03.11FEB03 RTN TO CLINIC C/O SWELLING,REDDNESS,SORE TO TOUCH AND WARM TO TOUCH.1ST SHOT GOT A LITTLE RED,2ND WAS LIKE THIS ONE.TX:MEDROLDONE AND BENADRYL
14hr p/vax had fever then brief episode of becoming limp, blue @ lips, eyes rolled back;no jerking;lasted <5min then was sleepy 5min but kept pt awake;the became like nl self;
Tested at hospital outpatient on 6/13/21/ Unclear why there was a delay in lab reporting of result.
Information has been received from a physician concerning an approximately 5 year old female patient with Down's syndrome and a lot of respiratory problems who in approximately April 2009 ("4 to 5 months ago"), was vaccinated with the first dose of PNEUMOVAX 23.  In approximately May 2009 ("1 month later"), the titer was done which showed the patient was not immune.  At the time of reporting, the outcome was unknown.  It is unknown if the patient sought medical attention.  Additional information has been requested.
vibration in top of her head that is randomly after second dose; feel vibration in her eyes; dehydrated; nauseous; throwing up; body chills; headache; bodyaches; This spontaneous case was reported by a consumer and describes the occurrence of HEAD TITUBATION (vibration in top of her head that is randomly after second dose), EYE MOVEMENT DISORDER (feel vibration in her eyes), DEHYDRATION (dehydrated), NAUSEA (nauseous) and VOMITING (throwing up) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017B21A and 032M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-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 HEAD TITUBATION (vibration in top of her head that is randomly after second dose), EYE MOVEMENT DISORDER (feel vibration in her eyes), DEHYDRATION (dehydrated), NAUSEA (nauseous), VOMITING (throwing up), CHILLS (body chills), HEADACHE (headache) and MYALGIA (bodyaches). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, HEAD TITUBATION (vibration in top of her head that is randomly after second dose), EYE MOVEMENT DISORDER (feel vibration in her eyes), DEHYDRATION (dehydrated), NAUSEA (nauseous), VOMITING (throwing up), CHILLS (body chills), HEADACHE (headache) and MYALGIA (bodyaches) outcome was unknown.            No concomitant medications reported by investigator.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.
Symptom occurred one hour after receiving Covid 2023 updated vaccination.  At first, red blotches appeared on both sides of neck area, then both of the areas turned a deeper shade of red, and the rash became itchy.
R arm redness, swelling and discomfort from shoulder to mid forearm 24 hr after. BENADRYL and KEFLEX symptoms resolved in 72 hr.
Red rash around site within 24 hours of vaccination; tender and spreading. Yesterday area brighter and warm to touch. Not sure if AE's resulted from vaccine or way it was administered. Went to ER on 8/31 for possible cellulitis. Doctor did not do testing just observation and circled area around site to continue monitoring. Doctor prescribed KEFLEX (7 days) antibiotic and started yesterday. Today vax site looks about the same - no improvements yet.
H1N1 administered pt waited in lobby 10 mins 35 mins later face, neck and arms itching.
Saturday evening experienced headache and nausea. Both symptoms continued and left upper arm began to feel hot and very painful and sore to touch which started later in the evening. Sunday all day nausea, headache and sore arm continued with chills and whole body feeling hot. I may have had a fever but did not confirm with thermometer. Treatment included increase hydration with water and rest. I felt like my normal self on Monday morning.
Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Sore arm) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy NOS and Asthma. Concomitant products included IRON for an unknown indication.    On 05-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYALGIA (Sore arm). The patient was treated with PARACETAMOL (TYLENOL) for Myalgia, at an unspecified dose and frequency. At the time of the report, MYALGIA (Sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Treatment information was not provided.
received a dose of Engerix-B instead of the dose of Twinrix; received a dose of Engerix-B instead of the dose of Twinrix; This case was reported by a pharmacist via call center representative and described the occurrence of wrong vaccine administered in a male patient who received HBV (Engerix B) for prophylaxis.   Co-suspect products included HAB (Twinrix) for prophylaxis and hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Engerix B, Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Engerix B and not applicable after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced wrong vaccine administered and incomplete course of vaccination. On an unknown date, the outcome of the wrong vaccine administered and incomplete course of vaccination were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. The patient received a dose of Engerix B instead of the dose of Twinrix, which led to wrong vaccine administered. Till the time of reporting, the patient did not receive the dose of Twinrix as he was due, which led to incomplete course of vaccination. The reporter did not have patient demographics or lot number and expiration date to provide.  No additional details were provided. The reporter consented to follow up.
pt recv vax 24OCT95 & exp inj site pain which lasted more than 2wks; f/u info was recv 21FEB96;
admitted on 9/9/2021 for cough Short of breath,loss of taste for 7-8 days.  Vaccinated for COVID in March 2021. SpO2 of 78%.  Placed on OptiFlow.  COVID tested positive 09/09/2021.  Treated for COVID-19 pneumonia.  Pulmonologist and ID specialist was on board.  Completed antibiotics (ceftriaxone and azithromycin), dexamethasone, remdesivir.  For chronic pain right knee post surgery, pain specialist was consulted.  Pain medicine adjusted.  Insulin dose adjusted. Clinically improving.  6 minute walk test done. Recommended oxygen administration is 1L at rest and 4L with exertion.  Continue DVT prophylaxis 2 more weeks. Patient is medically stable to be discharge Home on 9/19/21
Severe fatigue, headache, stabbing pain in left temple, stuttering, inability to form complete sentences and communicate, fever