chrisvoncsefalvay/vaers-outcomes huggingface dataset:
SEVERE CHILLS; FEVER; MUSCLE PAIN; HEADACHE; This spontaneous report received from a parent concerned a 22 year old female. The patient's weight was not reported and height was 64 inches. The patient's pre-existing medical conditions included the patient was not pregnant at the time of report. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978, expiry: UNKNOWN) dose was not reported, administered on 25-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 25-MAR-2021, the subject experienced severe chills. On 25-MAR-2021, the subject experienced fever. On 25-MAR-2021, the subject experienced muscle pain. On 25-MAR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from severe chills, fever, muscle pain, and headache on 26-MAR-2021. This report was non-serious. This case, from the same reporter is linked to 20210664040.
Swelling, redness, itching, tenderness at injection site Resolved in 2-3 days
This prospective pregnancy case was reported by a healthcare professional and described the occurrence of vaccine exposure during pregnancy in a 28-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline) for prophylaxis during pregnancy. Concurrent medical conditions included cat bite. On 19 November 2010 at 11:50 the subject received 5th dose of BOOSTRIX (.5 ml, unknown). Her last menstrual period was on an unspecified date and estimated date of delivery is 10 July 2011. The subject was exposed to BOOSTRIX during the first trimester. On 19 November 2010, at the time of vaccination with BOOSTRIX, the subject experienced vaccine exposure during pregnancy. At the time of report the outcome of the pregnancy was unknown. Follow-up information was received on 09 February 2011. It was reported that the conception was normal. No significant details regarding the pregnancy were reported. Follow-up information was received on 17 August 2011. It was reported that the patient gave birth to male twins via cesarean section, prematurely, at 34 weeks gestation on 03 June 2011. The infants were reported to be healthy, however, low birth weight was noted. Weight of one twin was 4.0 pounds and the other was 3 pounds and 4 ounces. Refer to case numbers A0942393A and B for details of the twins.
got the flu shot and got a really bad case of the flu. Found out the shot is only 50 pct effective; got the flu shot and got a really bad case of the flu. Found out the shot is only 50 pct effective; Initial information received on 12-Jan-2023 regarding an unsolicited valid Social Media serious case received from a consumer/non-hcp.  This case involves an unknown age and unknown gender patient who got the flu shot and got a really bad case of the flu. found out the shot is only 50 pct effective after receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), concomitant medication, vaccination(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (strength, formulation, lot number and expiry date: Unknown) via unknown route in unknown administration site for Flu.  On an unknown date the patient developed a serious event of got the flu shot and got a really bad case of the flu. found out the shot is only 50 pct effective (vaccination failure) (latency: unknown) following the administration of INFLUENZA VACCINE.  On an unknown date the patient developed a non-serious event of got the flu shot and got a really bad case of the flu. found out the shot is only 50 pct effective (influenza) (latency: unknown) following the administration of INFLUENZA VACCINE.Reportedly stated that It has not gotten any better through the years. So patient may not bother with it next year since it has not gotten more effective through the years.  Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the events   Outcome: Unknown for both events  Seriousness criteria: Medically significant for vaccination failure; Sender's Comments: Sanofi company comment dated 18-Jan-2023: This case involves an unknown age and unknown gender patient who got the flu shot and got a really bad case of the flu. found out the shot is only 50 pct effective after receiving vaccine INFLUENZA VACCINE. The time to onset is not reported with the role of the vaccine. Patient's past medical history was unknown. Additional information regarding condition at the time of vaccination, lab data, concurrent condition, Concomitant medication, past vaccination history excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of an individual vaccine cannot be assessed.
Pale dry  mark on macula proximal forearm, no pustule, no erythema
rt arm-swollen in area on outer aspect of upper arm 13.5cm x 17.5cm;scab @ inj site;hot to touch;from w/o discomfort;no lymphadenopathy;
Initial report received on 02 January 2013 from the Investigator participating in the post-marketing study under the reference number M5A16. A case of pertussis disease in a two-year-old female subject (initials not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance electronic database. The subject had received 4 doses of PENTACEL; lot number C3432AB received on 02 November 2009, lot number C3432AB received on 04 January 2010, lot number C3471AA received on 02 March 2010 and lot number C3664AA received on 24 January 2011 (routes and sites of administration not reported). Approximately 17months after the last dose, on 23 July 2012, the subject developed a cough with a whoop. The subject also experienced posttussive vomiting, and sleep disturbance. Laboratory testing included positive PCR on 30 July 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of Azithromycin starting on 31 July 2012 for five days. The subject was not hospitalized. At the time of final contact on 09 October 2012, the subject's cough had resolved. The duration of the cough was reported at that time as 28 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Inappropriate schedule of vaccine administered; some kind of nasal congestion; hairy throat; felt like cold coming up; hairy throat; dry; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered), NASAL CONGESTION (some kind of nasal congestion), OROPHARYNGEAL DISCOMFORT (hairy throat), NASOPHARYNGITIS (felt like cold coming up) and OROPHARYNGEAL PAIN (hairy throat) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Apr-2021, the patient experienced NASAL CONGESTION (some kind of nasal congestion), OROPHARYNGEAL DISCOMFORT (hairy throat), NASOPHARYNGITIS (felt like cold coming up), OROPHARYNGEAL PAIN (hairy throat) and DRY THROAT (dry). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). The patient was treated with ZINC at an unspecified dose and frequency; MULTIVITAMINS [VITAMINS NOS] at an unspecified dose and frequency and HERBAL EXTRACT NOS at an unspecified dose and frequency. At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered), NASAL CONGESTION (some kind of nasal congestion), OROPHARYNGEAL DISCOMFORT (hairy throat), NASOPHARYNGITIS (felt like cold coming up), OROPHARYNGEAL PAIN (hairy throat) and DRY THROAT (dry) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       no concomitant drugs were provided.
first two days : fever, chills aches and pains, throwing up ..most sever was my shoulder felt like I had been shot. ache was so deep and debilitating. could not use arm for days. ache still there to a lesser degree. Arm still painful and range of motion limited.  dose was administered at the very top of my arm into what seemed to be the joint. Never ever had a reaction like this. want to get my Covid shot but afraid to... could you please advise. Thank you.
Pt recv vax on 9/30/98; 5 min post vax pt exp headache, shortness of breath, tight throat & chest; pt hosp for anaphylaxis
Moderna Covid-19 vaccine that was beyond 30 day use by date was given to patient; Moderna Covid-19 vaccine that was beyond 30 day use by date was given to patient; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 vaccine that was beyond 30 day use by date was given to patient) and PRODUCT STORAGE ERROR (Moderna Covid-19 vaccine that was beyond 30 day use by date was given to patient) in a 61-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Mar-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 vaccine that was beyond 30 day use by date was given to patient). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Moderna Covid-19 vaccine that was beyond 30 day use by date was given to patient). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 vaccine that was beyond 30 day use by date was given to patient) and PRODUCT STORAGE ERROR (Moderna Covid-19 vaccine that was beyond 30 day use by date was given to patient) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported. It was reported that date the vial was initially stored in the refrigerator was 31-Jan-2022.   This case was linked to MOD-2022-525834, MOD-2022-525860, MOD-2022-525870, MOD-2022-525874, MOD-2022-525880, MOD-2022-525890, MOD-2022-525893, MOD-2022-525896, MOD-2022-525900, MOD-2022-525903, MOD-2022-525912, MOD-2022-525915, MOD-2022-525860 (Patient Link).
This spontaneous report as received from a female consumer of unknown age. The patient's medical history included liver infection and current conditions were not reported. On 14-OCT-2014 the patient was vaccinated with ZOSTAVAX (strength, dose and frequency not reported). Other co-suspects are not reported and concomitant medication includes unspecified blood pressure pills. On an unknown date, after a couple of days after the vaccination, the patient experienced unexplained severe back pain. It was reported that he went to see his physician and she sent him to have an MRI, CT scan and X-rays of his back, on an unspecified date, which all came back inconclusive. Consumer reports that he was prescribed hydrocodone with acetaminophen 5 mg/325 mg to treat the pain, and will also be seeing an unspecified rehabilitation specialist on 12-NOV-2014 (reported as tomorrow). Consumer also reports that his back began to feel better on an unspecified date (also reported as now seems to be getting worse again. The outcome of experience unexplained severe back pain was reported as not recovered/not resolved. The relatedness of the event with the therapy with ZOSTAVAX was unknown. Additional information has been requested.
Information has been received from a female consumer reporting on her approximately 65 year old husband with no drug reactions or allergies and no pertinent medical history who on 14-APR-2009, was vaccinated with a dose of ZOSTAVAX (Merck) (dose, route, lot number not reported). Concomitant therapy included vitamins (unspecified). In approximately 2011, about 1 year ago, the patient had a red, itchy, burning rash. On approximately 01-MAR-2012, about 4 months ago in the first week of March 2012, the patient developed the shingles in his left eye, his head, his face, mouth and down the left side of his body. Some of the shingles in those areas had gone away. It was also reported that the patient might lose his eyesight and he had no vision in his left eye. At the time of the report the patient's outcome was unknown. Skin biopsy of the rash was performed on an unknown date, results not provided. The patient sought medical attention via visiting the doctor. Upon internal review, no vision in his left eye was determined to be an other important medical event. Additional information has been requested.
administered only diluent portion; administered only diluent portion; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 2-month-old male patient who received Rota (Rotarix lyophilized formulation) (batch number 22952, expiry date 16th February 2024) for prophylaxis.   Co-suspect products included rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis.   On 22nd July 2022, the patient received Rotarix lyophilized formulation and Rotarix Oral Applicator Device. On 22nd July 2022, unknown after receiving Rotarix lyophilized formulation and Rotarix Oral Applicator Device, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered 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 Information: GSK Receipt Date: 27-Jul-2022 Reporter's Comments: The nurse reported that another nurse accidentally administered on 22nd July 2022 only the diluent portion of Rotarix to 2 patients. The reporter consented to follow up. Additional Supportive Information: The nurse reported that another nurse accidentally administered on 22nd July 2022 only the diluent portion of Rotarix to 2 patients, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. This case is 1 of 2 cases reported by the same reporter.; Sender's Comments:  US-GSK-US2022111744:Same reporter
ill / the flu or a cold as reported; Cold; received the first dose of Twinrix on 21-Dec-2019; This case was reported by a nurse via call center representative and described the occurrence of influenza in a patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included HAB (Twinrix) for prophylaxis.   On 21st December 2019, the patient received the 1st dose of Twinrix. On an unknown date, the patient received the 2nd dose of Twinrix. On an unknown date, less than a month after receiving Twinrix and not applicable after receiving Twinrix, the patient experienced influenza, cold and social problem. On an unknown date, the outcome of the influenza, cold and social problem were unknown.   It was unknown if the reporter considered the influenza and cold to be related to Twinrix.  Additional details were provided as follows: A nurse reported that a patient received the first dose of Twinrix. Approximately a month after that, this patient did not get dose two as the patient as ill (the flu or a cold as reported). This patient also did not get dose two till the time of reporting due to the COVID-19 outbreak. The reporter did not consent to follow-up.
This spontaneous report was received from a registered nurse referring to a 5 year old male patient. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 16-OCT-2017, the patient was inadvertently vaccinated with a dose of GARDASIL 9 lot number M036059 and expiration date of 03-JUN-2019 for prophylaxis (dose, route of administration, lot number and expiration date were not reported). The reporter stated that this was outside the recommendations per GARDASIL 9 prescribing information. No adverse effects were reported.
1917 patient reported dizziness, tightness in chest , hyperventilating and pulse rate of 118 bpm.
pain in injection site right; fatigue; nausea; headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (pain in injection site right ), FATIGUE (fatigue), NAUSEA (nausea) and HEADACHE (headache) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Fibromyalgia. Concurrent medical conditions included Asthma and Arthritis.    On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, the patient experienced FATIGUE (fatigue), NAUSEA (nausea) and HEADACHE (headache). On 04-May-2021, the patient experienced VACCINATION SITE PAIN (pain in injection site right ). On 04-May-2021, FATIGUE (fatigue), NAUSEA (nausea) and HEADACHE (headache) had resolved. At the time of the report, VACCINATION SITE PAIN (pain in injection site right ) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided. Patient stated that prior to vaccine, on 13APRIL2021 she consulted her HCP  for evaluation and was approved to receive the Moderna vaccine.   This case was linked to US-MODERNATX, INC.-MOD-2021-148240, US-MODERNATX, INC.-MOD-2021-148880 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-148240:Grand mother case US-MODERNATX, INC.-MOD-2021-148880:
Local injection site reaction with pain, and swelling.  6 cm in diameter area with mild erythema, swelling and firmness to palpation.
After initial soreness wore off, shot arm (left) has been partially disabled from full range of motion. Can't lift arm up high or backwards without extreme pain. Almost feels like a nerve is pinched.
This spontaneous report as received from a pharmacist via a company representative refers to a 83 year old female patient. The patient's medical history included shingles. On 05-SEP-2014 the patient was vaccinated with a 0.65ml dose of ZOSTAVAX. (lot#, strength, frequency and route unspecified). Within 24 hours after vaccination (approximately on 05-SEP-2014) the patient developed an active case of shingles. The outcome of shingles was reported as not recovered. Additional information has been requested.
given a 12 year old patient Daptacel instead of Adacel; given a 12 year old patient Daptacel instead of Adacel; Initial information received on 09-Jul-2019 regarding an unsolicited valid non-serious case received from a non-health care professional.  This case involves a 12 years old male patient who was vaccinated with a dose (sixth dose) of vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] instead of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (lot C5281AA and Exp. Date 05-Oct-2019) via unknown route in unknown administration site on an unknown date.  The patient's medical history not reported and concomitant vaccination included MENINGOCOCCAL VACCINE A/C/Y/W CONJ (DIP TOX) (MENACTRA) for Immunisation.  It was an actual medication error case due to wrong vaccine administered and inappropriate age at vaccine administration.  It was unknown whether the patient experienced any adverse event post vaccination.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Red, swelling, warm to the touch, and itching to left upper arm at injection site.
Headache, chills, temperature, tiredness, loss of appetite, extreme arm and shoulder pain with swelling and temperature at the sight of the vaccine. The first 5 side effects lasted 48 hours and the arm pain continued a weeks decreasing in intensity a bit each day.  No treatment sought just bed rest.
This is a spontaneous report from a contactable Pharmacist via Pfizer sales representative. A female patient in her 70's received PREVNAR 13 via an unspecified route of administration at single dose on an unspecified date for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced tender to touch for 2 weeks in area below arm around armpit on an unspecified date with outcome of unknown. No follow-up attempts are possible. No further information is expected.
An I take Tylenol for the pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (An I take Tylenol for the pain) in a  patient of an unknown age and gender 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 an unknown date, the patient experienced PAIN (An I take Tylenol for the pain). At the time of the report, PAIN (An I take Tylenol for the pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant Medications were provided by the reporter  No Treatment  information were provided by the reporter   Reporter did not allow further contact
approx 1hr p/vax rt deltoid became red, swollen, hot p/2hr area under arm & arm to elbow;also swollen, hot, red;pt applied ice & used motrin 2 days later redness is gone but whole arm to the elbow remains swollen;
3 months of shoulder pain in the (L) arm that was vaccinated. Began w/ intense burning at the site. It eventually went away.