chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Sore arm; Swollen lymph nodes; Chills; Slight fever; A little congestion; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), LYMPHADENOPATHY (Swollen lymph nodes), CHILLS (Chills), PYREXIA (Slight fever) and NASAL CONGESTION (A little congestion) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     The patient's past medical history included Depression, Anxiety and Asthma. Concurrent medical conditions included Penicillin allergy (Allergic to Antibiotic.) and Allergy to topical drugs (Allergic to Tamiflu (Antiviral Drug)). Concomitant products included CITALOPRAM, ETHINYLESTRADIOL, NORETHISTERONE ACETATE (MICROGESTIN) and HYDROXYZINE for an unknown indication.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm), LYMPHADENOPATHY (Swollen lymph nodes), CHILLS (Chills), PYREXIA (Slight fever) and NASAL CONGESTION (A little congestion). At the time of the report, PAIN IN EXTREMITY (Sore arm), LYMPHADENOPATHY (Swollen lymph nodes), CHILLS (Chills), PYREXIA (Slight fever) and NASAL CONGESTION (A little congestion) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment details were provided.
Really bad chills; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Really bad chills) and FATIGUE (Fatigue) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CHILLS (Really bad chills) and FATIGUE (Fatigue). At the time of the report, CHILLS (Really bad chills) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided No treatment information provided   Most recent FOLLOW-UP information incorporated above includes: On 14-Jul-2021: Follow up received on 14-JUL-2021 contains TCR document and No New information.
Red, itchy rash around the injection site - about the size of my palm.  I treated it with a topical cortizone cream and taking Benadryl orally.  The rash started to clear up gradually about a day after I started the treatment.  At six days now, the rash is mildly visible.  The itch continues somewhat. but not bad.
allergies; slight headache for a few weeks; left arm injection site still remains slightly raised; sinus infection; sore right arm for a few weeks; This spontaneous case was reported by a consumer and describes the occurrence of SINUSITIS (sinus infection), PAIN IN EXTREMITY (sore right arm for a few weeks), HYPERSENSITIVITY (allergies), HEADACHE (slight headache for a few weeks) and INJECTION SITE SWELLING (left arm injection site still remains slightly raised) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was reported.    On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Feb-2021, the patient experienced SINUSITIS (sinus infection), PAIN IN EXTREMITY (sore right arm for a few weeks), HEADACHE (slight headache for a few weeks) and INJECTION SITE SWELLING (left arm injection site still remains slightly raised). On 26-Mar-2021, the patient experienced HYPERSENSITIVITY (allergies). At the time of the report, SINUSITIS (sinus infection), PAIN IN EXTREMITY (sore right arm for a few weeks), HYPERSENSITIVITY (allergies), HEADACHE (slight headache for a few weeks) and INJECTION SITE SWELLING (left arm injection site still remains slightly raised) outcome was unknown.            Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the events was not applicable. Concomitant medications include Allergy Medicine. No Treatment information was  provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-059825 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-059825:cross_link report
no other AE; temperature excursion; This spontaneous report was received from a medical assistant and an office manafer and refers to a patient of unknown age and gender (number reported as 56173). There was no information about their concurrent conditions, concomitant therapies or medical history provided.  On 18-MAR-2021 (reported also as between 04-MAR-2021 and 25-MAR-2021), the patient was vaccinated with a dose of improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) dose/frequency: 1, lot # S030215, expiration date 25-MAR-2021, recombinant human albumin (rHA) (exact dose, route of administration and anatomical location were not reported) for prophylaxis. The vaccine was stored in a temperature of 13.5 Fahrenheit degrees (F) for 40 minutes. There was no previous temperature excursion reported. Digital data logger was involved. No additional adverse event was reported.  As of 28-MAY-2021, no further information was available as the office manager stated she was not familiar with the case and the medical assistant has not been working at the facility anymore.  This is one of several reports from the same reporter.
Terrible chills, body aches, fever 101.9 , HA , nausea.
Caller reports worsening hip and leg pain/her hips and legs feel real achy, she has achiness in her hips and legs; Caller reports worsening hip and leg pain/her hips and legs feel real achy, she has achiness in her hips and legs; her arm was sore yesterday but better today/her arm was sore; This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number: EL3247), via an unspecified route of administration in left arm on 20Jan2021 at single dose for COVID-19 immunization. Medical history included ongoing 'sometimes her hip and leg would hurt prior to getting the vaccine'.  There were no concomitant medications. Caller received the covid shot on Wednesday, 20Jan2021, her arm was sore yesterday (21Jan2021) but better today (22Jan2021). Caller reports worsening hip and leg pain on 22Jan2021 because sometimes her hip and leg would hurt prior to getting the vaccine. Caller would like to know if it's okay to have taken Tylenol for her symptoms after taking the covid vaccine. Response: The interim ACIP guidelines note that, "Antipyretic or analgesic medications (e.g., acetaminophen, non-steroidal anti-inflammatory drugs) may be taken for the treatment of post-vaccination local or systemic symptoms, if medically appropriate. However, routine prophylactic administration of these medications for the purpose of preventing post-vaccination symptoms is not currently recommended, as information on the impact of such use on Pfizer-BioNTech COVID-19 vaccine-induced antibody responses is not available at this time.& quot;  If you are a patient, you should discuss this with your healthcare provider. Caller would like to know how long the symptoms from the covid vaccine would last. Calling about the Pfizer COVID vaccine she took it on Wednesday (20Jan2021), the Pfizer Biontech, and yesterday (21Jan2021) her arm was sore all day, which is probably to be expected, but today (22Jan2021), she has, her hips and legs feel real achy, she has achiness in her hips and legs, it was asked if that is normal. it was asked if it is a side effect from the shot. Her arm is not like it was yesterday (21Jan2021) if the achiness was a side effect, she thought she may have had it yesterday (21Jan2021), but she didn't, just today (22Jan2021). The outcome her arm was sore yesterday but better today/her arm was sore was recovering. The outcome of other events was not recovered.
I had gone to the doctor for a check up the week before.  I am positive I did not have high blood pressure.  A few days after the vaccine,  my nose started bleeding.  I went to two ENTS because the first cauterization did not work.  The second ENT took my blood pressure and it was 146/112.   He suggested the ER.  I tried to go home and see if it came down on its own.  After a few more days, it was still so high that I went to the ER at hospital.  I have since had a full cardiac work-up, ekg, sonograms of the caratoid artery and heart, stress test and blood work.   I do not have any other issues.  I am still following up tomorrow to see if I need blood pressure medication.
Information has been received from a pharmacist referring to an unspecified number of college students of unknown age and gender. Concomitant therapy was not provided. On an unknown date the patients were vaccinated with ZOSTAVAX (dose and route unknown) (confirmed not VARIVAX) as a requirement to entering an university. Concomitant therapy was not provided. No adverse symptoms reported. Additional information has been requested.
Arm swollen and red, golf ball size. Advised to watch and see if it got any bigger, draw a circle around it. Call if she starts to act ill or run a fever. No treatment needed.
BODY ACHES; CHILLS; FEVER; SEVERE HEADACHE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 13-APR-2021, the subject experienced severe headache. On an unspecified date, the subject experienced body aches, chills, and fever. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 101 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, body aches, severe headache, and chills. This report was non-serious.
8 CM ROUND RED, RAISED AREA HOT TO TOUCH EVENING OF THE 19TH. WOKE AT 5:30 AM NEXT MORNING WITH FEVER AND NAUSEA. VOMITED X1 AND ARM WAS ITCHY. LG SWOLLEN AREA HAD GONE DOWN SOME, BUT SMALL ITCHY RAISED AREAS FROM ELBOW UP TO SHOULDER. TOOK 50 MG BENADRYL PO AND WENT BACK TO SLEEP. 10:00 AM LEFT SIDE OF NECK AND FACE WERE ITCHING BUT NO RASH. RAN LOW GRADE FEVER OFF AND ON ALL THAT DAY WITH ITCHING AS WELL.
This case was reported by a consumer via call center representative and described the occurrence of staphylococcal infection in a 15-year-old female patient who received FLULAVAL QUADRIVALENT 2018-2019 season) (batch number LB34Z, expiry date unknown) for prophylaxis. On 24th September 2018, the patient received the 1st dose of FLULAVAL QUADRIVALENT 2018-2019 season (intramuscular) .5 ml. On 8th October 2018, 14 days after receiving FLULAVAL QUADRIVALENT 2018-2019 season, the patient experienced staphylococcal infection (serious criteria GSK medically significant), injection site rash, injection site warmth, injection site itching, injection site lump, injection site erythema and injection site pain. The patient was treated with sulfamethoxazole + trimethoprim (Bactrim Ds). On an unknown date, the outcome of the staphylococcal infection, injection site rash, injection site warmth, injection site itching, injection site lump, injection site erythema and injection site pain were not recovered/not resolved.  It was unknown if the reporter considered the staphylococcal infection, injection site rash, injection site warmth, injection site itching, injection site lump, injection site erythema and injection site pain to be related to FluLaval Quadrivalent 2018-2019 season. Additional details were provided as follows: The case was reported by the patient's father. The patient received FLULAVAL QUADRIVALENT 2018-2019 season in the left deltoid. The product's expiration date was unknown. The patient presented lump on her arm that was as large as a tennis ball. The father reported that her daughter was seen by her physician and was prescribed Bactrim DS for a possible Staphylococcal infection. The father reported that his daughter planned to continue follow up with her physician on an unknown date.
Systemic: Fainting / Unresponsive-Mild, Additional Details: During the 15 minute observation period after recieving his vaccination, the patient fainted. Patient was conscious, given some water, and told to lay down for the rest of the observation period. No emergency responders required.
The fridge that contained the vaccines  temperature was out of range since July.  The office manager did not report the excursion and eventually moved the vaccines to an unregulated fridge.  While doing a on site review it was determined that the fridge had been out of range for days at a time rendering the vaccines ineffective.  A thermometer was placed on the fridge containing the vaccines and it was found to be way too low and thus those vaccines were determined to be ineffective as well. The manufactures were contacted and it was advised that all the pts be revaccinated.  I made several attempts with Facility to revaccinate roughly 400+ pts that received vaccines from July to Nov but was told by the staff to "stand down" and refrain from any further participation in the vaccine excursion. I was terminated in Jan and the pts still had not been offered revaccination.  This occurred at 2 of the locations.  The vaccines were still sitting on the managers desk in Jan when I was terminated.  I have further documentation and evidence to support the incident upon request.
This prospective pregnancy case was reported by a pharmacist and described the occurrence of vaccine exposure during pregnancy in a 29-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). On 17 September 2014, the subject received a dose of BOOSTRIX (administration site and route unknown). The last menstrual period and estimated date of delivery were not provided. The subject was exposed to the vaccine during the 3rd trimester, at 36 weeks of gestation. At the time of reporting, the pregnancy was ongoing. Please see case A1089876B for details regarding previous vaccination with DTaP during pregnancy. Follow-up information received on 08 October 2014 from the physician: The VAERS details were provided. Some of the patient's details were provided. On 17th September 2014, the patient received DTaP vaccine (intramuscular) .5 ml in pharmacy.
1/27/2022 Per patient's mom: patient is still expressing nausea, headaches, vomiting, chills lethargy and a low-grade fever for 2 plus days now.  Mom was very concern about the duration of these side effect symptoms and wanted it reported.
This spontaneous report as received from a physician refers to a female patient of unknown age. On an unknown date the patient was vaccinated with the second dose of GARDASIL (route, dose and lot # were unknown). On an unknown date the patient experienced meningitis. The patient saw a doctor. The outcome of meningitis was reported as recovering/resolving. Upon internal review, meningitis was considered to be a medically significant event. Additional information is not expected.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Feb-2021 at 3:45 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 28-Feb-2021 at 3:45 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient's age was reported as 74.92 years.  No concomitant medications were reported.  Batch Number 014M20A, vials sent to clinic were 20. Vial moved to fridge on 24-Feb-2021 and beyond use date for these vials was reported as 26-Mar-2021. Vial was moved to clinic on 27-Feb-2021. On 28-Feb-2021, same batch number vial was administered which underwent temperature excursion with temperature of 27 degrees Fahrenheit at 09:00 am and 26 degrees Fahrenheit at 01:00 pm.  On 28-Feb-2021, vials were stored in cooler 1, at following time and temperature respectively, 9 AM: 27 10 AM: 40, 11 AM: 44, 12 AM: 46, 1PM: 26, 2 PM: 37, 3 PM: 43 and 4 PM: 45.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34 or 35 degree Fahrenheit. Temperature recordings were taken using a traceable temperature monitor at every hour.  No treatment medications were reported.
Sore Arm for 3 days,  Slight headache that only lasted that evening, fatigue for 24 hours. Took tylenol to help
Tightness in throat and upper chest. BPs 160/100, 150/104. O2 sats 96%, then 93%. Taken to ED.
My symptoms started on April 24, 2022 I experienced constant irregular heartbeats; fatigue; tiredness; excessive sweating.
Fatigue and chest tightness during exercise after vaccination Myocarditis, cardiomyopathy
There was no adverse event , Reporting due to the recommendation of the FDA to no longer give monovalent vaccine
Pt recv vax on 10/26/98; on same day pt exp hot feeling, swollen eyes, cheeks, lips x 3 day
Lt arm sore itchy redness 4-28-08 - making her feel weird - disconnected - very tired, felt like vomiting the other day. Redness and swelling now diminished somewhat.
extreme flu like symptoms; extreme headaches on the right side of her head; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (over the past more than 20 years, some very severe.). Previously administered products included Shingrix (received 1st dose on unknown date).   In November 2019, the patient received the 2nd dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced influenza-like symptoms and headache. On an unknown date, the outcome of the influenza-like symptoms and headache were unknown.   It was unknown if the reporter considered the influenza-like symptoms and headache to be related to Shingrix.  Additional case details were reported as follows: The patient received Shingrix in November and had extreme flu like symptoms. Within the last couple days, she was having extreme headaches on the right side of her head.
Mild aphasia effecting speech.  Went into the ER and was hospitalized.  MRI and ultrasound confirmed stroke.
might be an allergic reaction; She could barely walk; It hurt to touch them as if they were bruised; they were bruised; injection site soreness/ It did hurt during administration; Injection site swelling; Significant knee pain (joint pain) inside both of her knees; This case was reported by a consumer via call center representative and described the occurrence of allergic reaction in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included arthritis (of the toes and lower spine).   On 30th October 2020, the patient received the 1st dose of Shingrix. In October 2020, 24 hrs after receiving Shingrix, the patient experienced allergic reaction, knee pain, walking difficulty, tenderness and contusion. On 30th October 2020, the patient experienced injection site pain and injection site swelling. On 6th November 2020, the outcome of the knee pain and tenderness were recovered/resolved. On an unknown date, the outcome of the allergic reaction, walking difficulty and contusion were unknown and the outcome of the injection site pain and injection site swelling were recovered/resolved.   It was unknown if the reporter considered the allergic reaction, knee pain, walking difficulty, tenderness and contusion to be related to Shingrix. The reporter considered the injection site pain and injection site swelling to be related to Shingrix.  Additional details were provided as follows: The patient had shot 1 of Shingrix in the left deltoid. The patient did not have the lot number. The patient was not sure if it was given intramuscularly because she looked away and did not see how long the needle was. The patient said that it hurt during administration and she said that her pharmacist told her that Shingrix tends to hurt and the injection site area was swollen and sore afterwards. The injection site soreness and swelling resolved after 2-3 days.   Within 24 hours after the Shingrix shot the patient had significant knee pain (joint pain) inside both of her knees and she could barely walk. It hurt to touch them as if they were bruised.  The patient wanted to report that she had no other change other than the Shingrix shot. She had no change to her diet or to her activity level. The patient reported the knee pain to her pharmacist and to her physician. The patient was concerned it might be an allergic reaction to Shingrix. She was concerned about whether or not she should get the second shot. The patient did some research online and she said she found in some online forums that others had reported joint pain. The knee pain lessoned and was resolved one week later.  The had a history of arthritis in her toes and lower spine and was on a unspecified medication and that arthritis did not flare up after the Shingrix shot. But the patient never had a problem with her knees before. The reporter consented to follow up.