chrisvoncsefalvay/vaers-outcomes huggingface dataset:
injection site developed a deep bruise and excessive swelling which went down after application of ice on it for few seconds
pt recvd vax in lt upper arm SC;5mins p/vax mom noticed red, raised area;eval by MD dx hive immunization rxn; no diff breathing;no other assoc s/s
Information has been received via a company rep from a physician concerning a male pt who on an unspecified date was revaccinated (after 5 yrs) with pneumococcal 23v polysaccharide vaccine (lot not provided). Subsequently, the pt developed an unspecified injection site reaction. The pt recovered from the injection site reaction without any intervention. Additional information has been requested.
Patient was given wrong vaccines in error. Was previously given MMR, Varicella and PCV13 on 4/16/2014. These vaccines were given again on 5/28/15 by error.
sciatic nerve pinching; had sharp pain, and area affected is left side of neck to lower hip; started having pain on left side of neck; This spontaneous case was reported by a consumer and describes the occurrence of NERVE COMPRESSION (sciatic nerve pinching), PAIN (had sharp pain, and area affected is left side of neck to lower hip) and NECK PAIN (started having pain on left side of neck) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013A21A, 069F21A and 069F21A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Dec-2021, the patient experienced NERVE COMPRESSION (sciatic nerve pinching), PAIN (had sharp pain, and area affected is left side of neck to lower hip) and NECK PAIN (started having pain on left side of neck). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event, at an unspecified dose and frequency. At the time of the report, NERVE COMPRESSION (sciatic nerve pinching) had not resolved, PAIN (had sharp pain, and area affected is left side of neck to lower hip) outcome was unknown and NECK PAIN (started having pain on left side of neck) had resolved.            No medical history was provided by reporter.  No concomitant medication was reported.  The feeling on sciatic nerve pinching was still ongoing, it comes and goes while sitting. It was not resolved completely.   This case was linked to MOD-2021-413868 (Patient Link).
This case was reported by a physician and described the occurrence of injection site reaction in a 2-year-old male subject who was vaccinated PEDIARIX. There were no concurrent medications.  In May 2008 the subject received 1st dose of PEDIARIX at 0.5ml. In May 2008, at unspecified time after vaccination with PEDIARIX, the subject experienced injection site reaction. At the time of reporting the event was worse.
patient received an expired dose; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 4-month-old female patient who received Rota (Rotarix lyophilized formulation) (batch number 432S2, expiry date 12th July 2022) for prophylaxis.   Co-suspect products included rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis.   On 15th July 2022, the patient received Rotarix lyophilized formulation and Rotarix Oral Applicator Device. On 15th July 2022, unknown after receiving Rotarix lyophilized formulation and Rotarix Oral Applicator Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was 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:18-JUL-2022 Reporter's Comment: The reporter reported that, a pediatric patient received an expired dose of Rotarix. The reporter consented to follow up. Additional Supportive Information: A pediatric patient received an expired dose of Rotarix, which led to expired vaccine used.
None. 11/16/10 Phone call to patient and spoke to mother - stated that patient has no problems after receiving the shot.
warmth, redness at injection site..approx. 2x4 inches..very itchy..bumpy feel..almost like a cellulitis
About 10 minutes after receiving vaccination, patient passed out in to the lap of her sibling and lost consciousness for about 5 seconds. Before fully coming to, she exhibiting an involuntary muscle response where her body was contorted. EMS did not believe it to be a seizure especially because the patient was alert and oriented when speaking to her.
Red, swollen arm and very hard, body aches, nausea, headache and chills
headaches and disorientation up to two weeks following shots, pain in testicles lasting upwards of 3 months after first dose
Developed persistent migraine symptoms three days after shot.  Nausea, dull neck ache, vertigo/coordination issues.  These persisted at a low level until examined by nurse practitioner at chiropractor office on September 2nd when they found my whole upper right back/neck inflamed and gave me dexamethasone injections.  NP and also now my general practioner, believe vaccine caused a significant inflammatory response in my neck and upper back. Steroid shots worked for a few days but low level migraine has returned and CT/neuro consult is pending.
Few minutes after receiving the shot, stood up to leave and then fell, hit head, and had a seizure. No one knows if the seizure was first or as a result of hitting her head.
This spontaneous report was received from a healthcare worker referring to a female patient of unknown age and unknown gender. Information about concurrent condition, concomitant medication and medical history was not provided. The patient reported she received VAQTA on unspecified date (strength, dose, frequency, route, lot #, expiration date and indication were not reported) for prophylaxis and experienced elevated liver enzyme on unspecified date. The outcome of elevated liver enzyme was unknown. The causality was not provided.
This spontaneous case, initially received from other non-health professional (consumer) on 26-Oct-2018, concerns a 47 year-old, adult female patient. On 16-Oct-2018, the vaccine underwent temperature excursion. On an unspecified date in Oct-2018, the patient was inadvertently administered FLUCELVAX QIVc that underwent temperature excursion [dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 252664 and expiry date: 30-Jun-2019]. The patient did not experience any adverse events after vaccination. The reporter assessed this as non-serious. This case (201805008) was cross-linked to the case: 201805002 reported by the same reporter. Follow-up received from other non-health professional on 13-Nov-2018: The onset date of the event incorrect product storage was updated as 16-Oct-2018 and expiry date of the suspect vaccine was updated as 30-Jun-2019. The reporter confirmed that, the patient did not experience any adverse events after vaccination. The reporter refused to provide the patient's initials and date of vaccine administration. The narrative and case comment were amended accordingly.
Patient was seen in our ER on 7-26-22 for AMS, sepsis, cystitis and was tested for covid upon arrival.  Patient was found to be positive and was admitted for further evaluation and treatment.
Individual vaccinated off-label, only 17 years old at time of vaccination. Date of birth falsified on consent form.
This spontaneous report was received from a currently 60 years old female, non pregnant, consumer with no pertinent medical history reported. On 15-JUN-2013 the patient was vaccinated with ZOSTAVAX (lot number and expiration date not reported) (1 vaccine, dose and route not specified) in the arm. No other suspect therapies or concomitant medications were reported. The patient stated that on an unknown date (also reported as "06") she had a red mark "as big as a softball" at the injection site. Outcome for red mark at the injection site was unknown at the time of the report. The patient stated that no treatment was given for the red mark at the injection site. It was reported that the patient did not seek medical attention. Additional information is not expected.
Information has been received from a medical assistant referring to an unspecified number of patients of unknown age and gender. The patients' medical history and concurrent conditions were not reported. Concomitant therapies included sterile diluent (manufacturer unknown). On 01-SEP-2017, the patients were vaccinated with improperly stored VARIVAX (dose, frequency and route were unknown, lot # M049127, expiration date: 15-DEC-2018, lot # N010107, expiration date: 28-MAR-2019) for prophylaxis. Administered vaccine experienced the temperature excursion of -14 Celsius degree to -10 Celsius degree (-14.2 Celsius degree) for 6 hours. There was no previous temperature excursion. Data logger was involved. No adverse effects reported. No product quality complaint (PQC) was involved. This is one of several reports from the same reporter. All telephone attempts on 10-OCT-2017 to obtain follow up information have been unsuccessful. Follow up information has been received from an other reporter concerning a 13 month old patient. On 08-SEP-2017, the patient vaccinated with improperly stored VARIVAX (dose, frequency and route were unknown, lot # N010107, expiration date: 28-MAR-2019) for prophylaxis. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1709USA002098: US-009507513-1709USA002186.
Tdap administered @ ~ 2:00 PM. Phone call from husband at 3:15 pm. Client fine until about 2:45 pm when driving home. Onset of nausea, loss of vision, heaviness on chest, light-headedness while driving; pulled to roadside and flagged down help who called client's husband. Husband arrived and took client home; called in to HD at 3:15 with report of symptoms, eased slightly now, but not back to normal. Advised husband to take client to E.R. She doesn't want to go d/t lack of insurance and symptoms less than previously. Advised to take 50 mg Benadryl now. If sx increasing or not resolved in 30 minutes, to E.R. 3:40 pm, client and husband walked into HD. Client nauseated, shaking, diaphoretic with labored breathing without wheezing. Walked next door to Medical Clinic for assist with response. 3:45- Adult Epi-Pen administered- breathing eased per client. oxygen applied, vitals taken by Medical staff. Paramedics transported to another Hospital E.R. @ ~ 3:55pm.
whole left side is swollen/onto my left neck and my left shoulder, my left arm and my whole left side to my waist it feels like a jelly fish kind of swelling; My arm and my left arm started swelling; onto left neck and left shoulder, left arm and whole left side to waist it feels like a jelly fish kind of swelling/not just swollen arm its huge it's quarter of my body my left side is swollen; onto left neck and left shoulder, left arm and whole left side to waist it feels like a jelly fish kind of swelling/not just swollen arm its huge it's quarter of body my left side is swollen; onto left neck and left shoulder, left arm and whole left side to waist it feels like a jelly fish kind of swelling/not just swollen arm its huge it's quarter of body my left side is swollen; This is a spontaneous report based on information received by Pfizer from Concentrix via a contactable consumer (patient).   A patient of unknown age and gender received second dose of received second dose of BNT162B2 (PFIZER-BIONTECH m-RNA COVID-19 VACCINE, formulation: Solution for injection, Lot number and expiry date was not reported), via an unspecified route of administration on an unspecified date as Dose 2, single for Covid 19 Immunization. Medical history and family history was not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: Solution for injection, Lot number and expiry date was not reported) via an unspecified route of administration on an unspecified date for Covid-19 immunization. Patient did not experienced any event after first vaccine and was fine. The patient's concomitant medications were not reported. The patient had second Covid vaccine last thursday (unspecified date in 2021) and immediately under arm and left arm started swelling. Since then, the patients left neck, left shoulder, left arm and whole left side to waist felt like jelly fish kind of swelling, it was not hard its soft movable and it kept getting worst and it was not just swollen patients arm its huge it's quarter of patient's body. Left side was swollen but neck, shoulder, and arm, under arm down to waist and so half part of waist has movable swelling. The outcome of all events was unknown.   No follow-up attempts are needed. information about lot/batch number cannot be obtained. No further information is expected.
PT. CALLED AND REPORTED ADVERSE REACTION AFTER COMPLETION OF DOSING. PT. STATED MILD ITCHING AFTER EACH DOSE AND WORSENING WITH EACH SUBSEQUENT PILL TAKEN. ON FOURTH DOSE A RASH DEVELOPED ON TORSO, ARMS, AND HEAD. NO SOB REPORTED. RASH DESCRIBED WAS SMALL AND PIMPLELIKE. SHE TOOK BENADRYL AND THE S/S RESOLVED.
VOMITING AT 2 AM,  FEVER (102 DEGREES), LOSS OF APPETITE CONTINUED THROUGHOUT ENTIRE DAY.
This spontaneous report as received from a health professional (nurse) refers to an 18 year old patient. Patient's medical history, concurrent conditions and drug reactions/ allergies were not reported. On an unknown date the patient was inadvertently vaccinated with an adult formulation of RECOMBIVAX HB, 10 Microgram (inappropriate schedule of drug administration). Concomitant therapy was not reported. No adverse effects were reported. Additional information has been requested.
Allergic reaction from the vaccine; Fever; It was very hard for me to breath; This is a spontaneous report received from a contactable consumer(patient). A 28-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 14Jun2021 (Lot Number: ER8736) (at age of 28-year-old) in Left upper arm as DOSE 2, SINGLE for covid-19 immunisation.  The patient medical history and concomitant drugs was not reported. There was no prior vaccination (within 4 weeks).  The patient previously took the first dose of BNT162B2 on 07May2021 (at age of 28-year-old) (Lot: EWO164, not sure if this O or 0) for COVID-19 Immunization.  The patient experienced allergic reaction from the vaccine (hypersensitivity) (hospitalization), fever (pyrexia) (hospitalization), it was very hard for me to breath (dyspnoea) (hospitalization), all on 14Jun2021. Consumer stated, "I had my first dose of Pfizer vaccine 07May2021 and my second one is on 14Jun2021 and on 14June night, I started to have like a fever and it was very hard for me to breath. So, I waited to like a few hours I might feel little bit better but my condition got worse. So, I decided to go to an emergency room. On June 15, early morning and  as a resort of that, they gave like a medicine there they managed my breathing problem and my fever and so I went home. And as a resort of that I have a medical bill of # dollars. So, I get energy care and the following morning like 7  they have prescribed me a medicine for allergy, it is like an allergic reaction so like for the allergic reaction that I have from the vaccine, So, after administration of medicine for hour my fever brought down I was able to somehow breathe and everything is manageable at my end." When clarified, consumer stated, "Basically, I was able to breathe a little, what they did in emergency room they just managed me in order for me to breath and all that and then they released me but I still have some fever but I was able to breath. So, it was early morning it was like 3 o'clock in the morning so there was no urgent care or any facility that I can go apart from emergency department at that hour. So, I was able to breathe. So, upon discharge I did take the medical services of an urgent care like 7 o'clock in the morning and they are the ones that prescribed me the medicine for allergy which I bought but that is all started out." Treatment: Consumer stated, "Saline nasal spray, Albuterol Sulfate, its inhalation aerosol inhaler 90 mcg and other one is antihistamine and other one is just Tylenol." The outcome of the events was resolved on 15Jun2021.   Follow-up attempts are completed. No further information is expected.
This case was reported by a lawyer and described the occurrence of joint pain in a male subject of unspecified age who was vaccinated with LYMERIX. A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose of LYMERIX (unknown). At an unspecified time after vaccination with LYMERIX, the subject experienced pain in his joints and muscles, headaches, flu-like symptoms, fatigue, possible memory loss, cognitive dysfunction, rashes, vision disorders, cardiac problems, insomnia, and decreased activities of daily life. it was reported that she experienced, among other things, rheumatologic, neurologic, and/or cognitive impairment of an autoimmune, immune-mediated, or other mechanism, all caused by vaccination with LYMERIX, including, but not limited to, the events above. At the time of reporting the outcome of the events were was unspecified. This information was received via a Statement of Injuries. Follow up information was received on 29 February 2007 via information obtained from an interview between the subject and lawyers. The subject received the first, second, and third doses of LYMERIX in October 1999, December 1999, and December 2000. In March 2000, the subject developed muscle and joint aches. In 2000, he began experiencing nightmares. In approximately 2001 he developed an irregular heart beat. In approximately 2002, he experienced loss of libido with swollen scrotum, and "shortly" thereafter developed depression, "lack of social activities", and short temper. In approximately 2006 he experienced memory loss. In approximately 2007 he developed anxiety. On unspecified dates, he experienced blood clots in his legs and methicillin resistant staphylococcus aureus (MRSA) infection. He indicated that he required stent placement for treatment of irregular heartbeat. He underwent carpal tunnel surgery, and surgery with removal of a "lap lesion" and bone spur from the subject's shoulder. Other treatment included an unspecified mood stabilizer, EFFEXOR, XANAX, and possibly VIAGRA. He reported two blood clots that occurred at different times, one in the left leg above the knee, and later one in the right leg above the knee. Blood clots were treated with HEPARIN and COUMADIN. He was hospitalized due to MRSA, and was treated with antibiotics. In September 2008, he experienced suicidality and was hospitalized, and subsequently received behavioural counseling. With the exception of MRSA, blood clots, and irregular heartbeat, the events were unresolved at the time of this report.
15 hours of Flu-like symptoms: Bad Headache, fever, chills, muscle aches, joint pain, extreme fatigue
WORSENING GRANULOMA ANNULAR; CONFUSION OF DAYS; JOINT PAIN; BACK PAIN; BODY PAIN; BONE PAIN; HEADACHE; NAUSEA; This spontaneous report received from a patient concerned a 56 year old. The patient's weight was 213 pounds, and height was 69 inches. The patient's concurrent conditions included azithromycin allergy, tetracycline allergy, sulfa allergy, dye allergy, shell fish allergy, bee sting allergy, wasp sting allergy, non alcohol user, non smoker, and granuloma annular, and other pre-existing medical conditions included patient had no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 01-APR-2021, the subject experienced nausea. On 02-APR-2021, the subject experienced bone pain. On 02-APR-2021, the subject experienced headache. On 03-APR-2021, the subject experienced back pain. On 03-APR-2021, the subject experienced body pain. On 03-APR-2021, the subject experienced confusion of days. On 03-APR-2021, the subject experienced joint pain. On 06-APR-2021, the subject experienced worsening granuloma annular. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from bone pain, nausea, headache, back pain, body pain, and joint pain, and had not recovered from worsening granuloma annular, and confusion of days. This report was non-serious.
No additional AE information provided; PNEUMOVAX 23 syringes experienced a temperature excursion on March 21, 2022; This spontaneous report was received from a medical assistant referring to an unknown number of patients of unknown age and gender. The patients' concurrent conditions, medical history, drug reactions/allergies and concomitant therapies were not reported.  Pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) syringes (lot #T033369, expiration date: 26-MAY-2022; lot #T039322, expiration date: 09-SEP-2022) that experienced a temperature excursion on 21-MAR-2022 may have been administered (strength, dose and route were not provided) to patients for prophylaxis after that date (product storage error).  The aforementioned doses of vaccine experienced a temperature excursion in 30.2 degrees Fahrenheit (F) for 7 hours 45 minutes. There was no previous temperature excursion. The reporter was not able to provide any additional details at this time. No additional adverse event (AE) information provided.   Follow up information has been received from the medical assistant on 23-JUN-2022. The patient was 63-year-old male. The vaccine was administered by medical assistant in the left deltoid. The patient was vaccinated at private doctor's office/ hospital and the vaccine was purchased with private funds. Temperature excursion occurred as a result of a reading from a Digital Data Logger. On 21-MAR-2022, current temperature was 30.2 degrees (min 37.9-max 41.8) at 4:30 pm and 41.5 degrees (min 37.7-max 42.4) at 7:45 am. The pm read appeared to be written wrong, possible 38.2 degrees vs 30.2, but to be safe it was removed from inverting. It was not available for return as it was destroyed. ; Sender's Comments:  US-009507513-2205USA003408:
Onset fever, headache, sore throat, cough and slight bronchospasm which persisted on and off 10/16-10/21. Developed secondary left lower lobe bacterial pneumonia on 10/21/09. Treated in ER. TAMIFLU given 10/16-10/21-full 5 d course.
Pt received both COVID (Pfizer) vaccines (on 3/3/21 and 3/24/21 respectively), but still tested positive for COVID on 10/30/2021 and required hospitalization on 11/8/21 until 11/10 for treatment of COVID and a fib.