chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a physician, pharmacist and health professional, refers to a 2 year old male patient with allergy to dogs and cats but no food allergies. On 26-MAR-2015 the patient was vaccinated with a dose of VARIVAX (Merck) (lot # K009757, expiration date 09-JUL-2016) 0.5 ml in the right thigh. None concomitant therapy or medical history were reported. On 02-APR-2016, the patient was presented with 3 or 4 pimples on the left side, on the front left abdomen area extending into the upper groin area above the pubic area. The rash extended to the back on the left side only. The patient was afebrile. Only pain as other systemic symptoms was reported. On the same day, 02-APR-2016, the patient was seen in the office by a physician. On 04-APR-2016, the patient had grew quarter size, raised bumps like a rash/burn. On 05-APR-2016, the patient was seen again at the office with vesicles on the rash and the patient was diagnosed with shingles. The patient was placed on ZOVIRAX 200mg/5ml with dose of 6 ml PO four times per day (5 day treatment). On 08-APR-2016, the rash had progressed to an "iron size rash" and "it was now had expanded from left side of belly to his left rear end cheek". The rash did not occur at the site of injection. The patient had numerous to count rash, grouped vesicles, erythematous base and the patient was seen again to another primary doctor and ZOVIRAX dose was changed to 4.5ml PO, 5 times per day (another round of 5 day treatment). On 14-APR-2016, the patient was seen in the office by physician and a specimen was collected to send to the Varicella Zoster Virus Identification Program (VZVIP) for polymerase chain reaction (PCR) testing. The patient was also diagnosed with impetigo at this time and placed on an antibiotics as KEFLEX 250/5ml PO, 3.5ml twice daily for 10 days and BACTROBAN 2% topical ointment: 1 application 3x daily for 10 days. At the time of report, the patient was not recovered at this time and no follow-up was planned. The relatedness between vaccination of VARIVAX (Merck) and shingles and impetigo was not reported. Additional information has been requested.
At about day six, I developed a headache that didn't respond to Tylenol. I got joint aches in my arms, legs, and back. The headache triggered the doctor to do a CT scan which was clear, no blood clots found. The joint pains lasted about 10 days to 2 weeks and eventually went away. I have developed hamstring issues and bursitis in both of my ankles/feet area and being treated for that.
Began having bad chills and body aches around 8:30 pm - fell asleep, woke up and checked fever and was 101.1.  Body ached so bad it felt like my legs were gonna fall off.  Took 4 Ibuprofen and 2 hrs later woke up from my heart pounding out of my chest.  Felt like I was burning up - took temperature again and was 101.5.  Heart rate was 144 bpm - went to ER, received fluids and Ativan.
Swelling at the injection site Large circle of redness at injection site Itching Injection site pain
This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (patient experienced COVID-19) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The patient's past medical history included Idiopathic urticaria and Hip osteopenia. Concomitant products included COLECALCIFEROL, GENISTEIN, ZINC AMINO ACID CHELATE (FOSTEUM), CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), FAMOTIDINE (PEPCID [FAMOTIDINE]), NIRMATRELVIR, RITONAVIR (PAXLOVID) and MONTELUKAST SODIUM (SINGULAIR) for an unknown indication. On 29-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Aug-2022, the patient experienced COVID-19 (patient experienced COVID-19). At the time of the report, COVID-19 (patient experienced COVID-19) was resolving. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No treatment medications were provided by the reporter. Company comment: This spontaneous case concerns a female patient aged 64 years with no relevant medical history reported, who experienced the unexpected non-serious AESI of Covid 19 that occurred approximately 17 months after a dose (dose number not specified) of mRNA-1273 vaccination. No further information on risk factors, detailed clinical course, investigations, treatment of the events and details pertaining to the doses was available in the report. Outcome of the event Covid 19 was resolving at the time of report. The current pandemic situation of COVID 19 may remain as confounder to the event Covid-19. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness (non-serious) assessed as per medical judgement and available information. Sender's Comments: This spontaneous case concerns a female patient aged 64 years with no relevant medical history reported, who experienced the unexpected non-serious AESI of Covid 19 that occurred approximately 17 months after a dose (dose number not specified) of mRNA-1273 vaccination. No further information on risk factors, detailed clinical course, investigations, treatment of the events and details pertaining to the doses was available in the report. Outcome of the event Covid 19 was resolving at the time of report. The current pandemic situation of COVID 19 may remain as confounder to the event Covid-19. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness (non-serious) assessed as per medical judgement and available information.
Recognized Flublok inadvertently given to patient under 18 years of age. No side effects noted per mom
t104, resp 60, HR-148; pt taken to ER; sponge bath given;
Caller felt like she was bite by insect on left arm, arm was sore and there is a bump, had bad headache yesterday and could not even get up. Visited pharmacist said if this was the reaction with the first shot that the second will be much worse. and she would have been warned because she has MS. And her voice changed to be very raspy.  Caller is unable to eat, if she3 eats she throws up
Rash around neckline, first appeared like a bad sunburn. Not irritated or raised surface, almost hive like. Gave Benadryl and increased fluid intake. Rash improved and is now peeling over the course of 5 days. No pain or itching.
Information has been received from a medical assistant concerning a 7-year-old female patient with no allergies, who on 09/23/1999 at another physician's office, was vaccinated with varicella virus vaccine live (Oka/Merck). On 11/09/2005 the patient developed a rash with less than 30 lesions on her trunk and arms with itching. She presented to the physician's office on 11/10/2005 and is reported to have a chicken-pox breakthrough. It was noted that her brother had shingles 10 days ago (approximately 11/01/2005) There was no product quality complaint reported. Additional information has been requested.
Right axilla swelling tenderness and constant pain due to probable lymph node swelling treated with ibuprofen but it?s not really helping
husband is suffering terrible to this week from shingles; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced shingles (Verbatim: husband is suffering terrible to this week from shingles).  The outcome of the shingles was not resolved.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.     It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 17-SEP-2023 This case was reported by a patient's wife via interactive digital media. The reporter stated that her husband suffering terrible to this from shingles. The reporter and the patient both received 1st shots two months ago. The vaccine did not keep the patient from getting shingles. The patient had a very bad case. Follow-up was not possible as no contact details were available.
Severe insomnia that has persisted even as other side effects have calmed; Fever; Chills; Chest pain; Loss of appetite; pressure at the sternum; neck pain; Nausea; constipation; Severe joint pain in knees; lower back pain; This is a spontaneous report from a non- contactable consumer. A 33-years-old female patient received bnt162b2 (COVID 19, brand=Pfizer, Formulation: Solution for injection) via an unspecified route of administration in left arm on 23Mar2021 at 12:30 as dose 1, single and dose 2 via an unspecified route of administration in left arm on 13Apr2021 (at the age of 33-years-old) at 11:00 as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took ibuprofen and experienced hypersensitivity. Patient is not pregnant and No other vaccine in four weeks and no other medications in two weeks. No covid prior vaccination and no covid tested post vaccination. On 13Apr2021 at 20:30, the patient experienced severe insomnia that has persisted even as other side effects have calmed, fever, reoccurring for 2 days after 2nd dose, ranging from 101.1 - 104.2, chills, chest pain, pressure at the sternum, severe joint pain in knees, pain in lower back and neck and nausea and constipation, loss of appetite. The patient underwent lab tests and procedures which included body temperature with 101.1 - 104.2. No treatment received for the adverse events. The outcome of the events were not resolved.  No follow up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
The patient received vaccine Thursday Feb 17th around 10:30AM and started to experience symptoms the following day. The symptoms included Bell's palsy on the left side of her face with pain in her left ear and left armpit. She thought she was experiencing a stroke as the left side of her face lost feeling.
Sick on 17May  Positive Covid on 17May Took Paxlovid starting 5/18. Fever and chills for 2 days. Covid test negative on 5/26.; Sick on 17May  Positive Covid on 17May Took Paxlovid starting 5/18. Fever and chills for 2 days. Covid test negative on 5/26.; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 71-year-old male patient received BNT162b2 (BNT162B2), on 06Apr2022 at 08:00 as dose 4 (booster), single (Lot number: FK9894) at the age of 71 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no known allergies. 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 18May2022, outcome "recovered" (07Jun2022) and all described as "Sick on 17May Positive Covid on 17May Took Paxlovid starting 5/18. Fever and chills for 2 days. Covid test negative on 5/26.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (18May2022) positive, notes: positive; (26May2022) negative, notes: negative; (29May2022) positive, notes: positive; (07Jun2022) negative, notes: negative. Therapeutic measures were taken as a result of drug ineffective, covid-19. From 18May2022 to 22May2022, the patient was treated with Paxlovid (oral) for COVID-19. Clinical course: Patient was sick on 17May and was covid positive on 18May. Took Paxlovid starting 18May. Fever and chills for 2 days. Covid test negative on 26May. Patient developed runny nose on 27May. Covid test was positive on 29May. Runny nose for a few days. Covid test negative on 07Jun. No symptoms on 07Jun. Patient had no known allergies. Patient had not received any Other medication in 2 weeks.  No follow-up attempts are possible. No further information is expected.; 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.
patient stated they got a bruse right away after reciving the vaccine that lasted FOR 1 WEEK AFTER GETTING vaccinated. They also said they got a sore arm.
Rash all over his body; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash all over his body) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In June 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced RASH (Rash all over his body). At the time of the report, RASH (Rash all over his body) outcome was unknown.            After the symptoms started patient went to see an allergist to do a scratch test for food and environmental allergy. The test indicated that he was not allergic to anything. The only thing he can relate the reaction to was the vaccine.  No concomitant medications were reported.  No treatment medications were reported.
Patient reported having sweeling and redness to area that has gotten worse over the course of 5 days.
On 1/16 11:00 am?5 pm I had chills that would not subside. From 7 pm to 12 midnight I had a fever. It went from 99 to 101 to 104.3 and finally dropped back to 99 before bed at midnight. The next day, 1/17, I had fatigue all day and body aches. 1/18 I had neck pain and a headache in the back of my head.
flu from a flu shot; Initial information was received on 12-Oct-2020 regarding an unsolicited valid non-serious  case from the patient via social media.  This case is linked to cases 2020SA294135, 2020SA294140, 2020SA294160, 2020SA294161, 2020SA294162, 2020SA294163, 2020SA294142, 2020SA294143, 2020SA294164, 2020SA294165, , 2020SA294145, 2020SA294166, 2020SA294167, 2020SA294174, 2020SA294175, 2020SA294146, 2020SA294147, 2020SA294148, 2020SA294168, 2020SA294169, 2020SA294149, 2020SA294170, 2020SA294171, 2020SA294151, 2020SA294172, 2020SA294173, 2020SA294150, 2020SA294152, 2020SA294153, 2020SA294154, 2020SA294155, 2020SA294156, 2020SA294136, 2020SA294137, 2020SA294157, 2020SA294158, 2020SA294125, 2020SA294138, 2020SA294139, 2020SA294159 and 2020SA294231 (same reporter).  This case involves an unknown demographic patient who had flu from the shot (influenza) while the patient received INFLUENZA VACCINE.  The patient's medical history, past medical treatment(s), vaccination(s), family history and concomitant medications were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer, batch number and other dosing details were not reported) for prophylactic vaccination.  On an unknown date, the patient had flu from the shot (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  Details of laboratory data were not reported.  Corrective treatment was not reported.   The event outcome was unknown.  There will be no information available on the batch number for this case.
11 Doses administered after 30-day Use By Date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (11 Doses administered after 30-day Use By Date) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (11 Doses administered after 30-day Use By Date). On 05-Jan-2022, EXPIRED PRODUCT ADMINISTERED (11 Doses administered after 30-day Use By Date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that the Moderna vaccine put out of the freezer on 01-DEC-2021 and placed in the refrigerator, so it was not supposed to be used beyond 31-DEC-2021 but 11 doses were administered on 05-JAN-2022. And also stated that the vial did not undergo any temperature excursions.  Concomitant medication information was not reported Treatment information was not reported
Warm, red area around immunization site. Next morning, swelling and redness decreased leaving hard lump in upper (R) arm. No pain, or limitation.
1st and 2nd dose  were year apart; This case was reported by a consumer via interactive digital media and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (received 1st shot on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK receipt date: 25-Oct-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient had first and second shingles shots were more than a year apart. The patient asked that he/she need a booster. Additional supportive information: The patient received 2nd shot of Shingles vaccine later than recommended interval, which led to lengthening of vaccine schedule. The follow-up could not be possible as no contact details were available.
received vaccines after a temperature excursion; This non-serious case was reported by a other health professional and described the occurrence of incorrect storage of drug in a 1-year-old patient who received Hepatitis A vaccine (batch number LY35X) for prophylaxis.   On 19-JAN-2023, the patient received the 2nd dose of Hepatitis A vaccine. On an unknown date, an unknown time after receiving Hepatitis A vaccine, the patient experienced incorrect storage of drug (Verbatim: received vaccines after a temperature excursion). The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK receipt date: 14-APR-2023 The reporter consented to follow-up. This case is for one of 119 patients, reported by same reporter. The patient received unstable vaccine after a temperature excursion, which led to incorrect storage of drug.; Sender's Comments:  US-GSK-US2023054677:same reporter US-GSK-US2023AMR055743:same reporter
VAERS completed because of being Tested positive for COVID-19 infection 14 or more days after being fully vaccinated. 1st dose03/07/21 2nd dose Diagnosed covid positive:08/28/2021 Symptom onset:08/29/21 Exposure:tavel Symptoms:cough
Information has been received from a consumer concerning her currently 7 year old son who was vaccinated on an unspecified date with a dose of MMRII (Lot # not reported) (manufacturer unknown).  The pt's mother reported that subsequently the pt developed mercury induced autism and this was reported to be disabling.  The pt was seeing a physician and it was reported that treatment (unspecified) was required.  No further information is available.
This case was reported by a other health professional via sales rep and described the occurrence of seizure in a 18-year-old male patient who received HAVRIX pediatric (batch number ZT5K4, expiry date unknown). Co-suspect products included BEXSERO (batch number 157101, expiry date unknown). Concomitant products included GARDASIL. On 9th June 2017, the patient received HAVRIX pediatric .5 ml and BEXSERO .5 ml. On 9th June 2017, less than a day after receiving HAVRIX pediatric and BEXSERO, the patient experienced seizure (serious criteria GSK medically significant) and syncope. On 9th June 2017, the outcome of the seizure and syncope were recovered/resolved. The reporter considered the seizure and syncope to be possibly related to HAVRIX pediatric and BEXSERO. Additional details were provided as follows: No hospitalization and no falling injury were reported. The patient was observed by healthcare professional (HCP). No any seriousness criteria was mentioned in the case as life threatening, death, persistent or significant disability/incapacity and congenital anomaly or birth defect. It was unknown if the events require surgical or medical intervention to prevent one of the outcomes described in preceding questions.
pt recv vax & had a fever, vomiting & was shaky the day p/vax;mom instructed to contact hlth dept;c/o feeling cold & shaky
T 99.8, R 44, O2 94%, Pulse 132, Bp 199/82. Patient lethargic, confused, weak. Sent to local ED, and ED reported resident had MI and was transferred to another hospital for further workup. Patient tested positive for Listeria in urine at local ED as well, which may have contributed to this reaction.
Rash - 2d ago noted on trunk a pink bump w/ a central clear blister in center. Noted another one on trunk yesterday and a few other spots developed but those are just tiny skin colored/pink bumps - no clear fluid. No exposures. Did have varicella vaccine 7/28/16.
Janssen COVID-19 Vaccine EUA 12 am - 1 am: Chills, shivering, couldn't get warm. Temperature 98.9 degrees F 3:30 am: Woke up feeling very hot. Temperature 100.6 degrees F (Fever). Slight headache/muscle aches, and shortness of breath but those could be due to the fever. Took two 500 mg Tylenol tablets.  7:30 am: woke up due to alarm, temperature back down to 98.6 degrees F.  10:00 am: still feeling a little ache-y, shortness of breath, and tired. No more fever.
Aches, pain, fever although not documented but felt like I had one, cough, runny nose.   Contracted from my husband 2 days after he tested positive at same facility as above.
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 24-NOV-2009, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) at a clinic, as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 22-DEC-2014, the patient was treated for a vesicular rash, which was diagnosed as herpes zoster or shingles. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.