chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    Concurrent medical conditions included Plaque psoriasis.   In September 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In September 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced PYREXIA (Fever). At the time of the report, PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported.   The patient stated that Skyrizi has never relieved her condition and when she saw the dermatologist, dermatologist did not think that she had psoriasis. She also had fever after Covid vaccine.  It was unknown if she was enrolled in a COVID-19 vaccine trial. No treatment information was provided. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Received H1N1 mist 10-7-09- started s/s of N/V- low grade temp that HS- improved next.
Pt. got the ZOSTAVAX shot on 9/7/12. Immediately the site of injection started itching & turned pink. She called back on 9/8/12, saying site was swollen (size of an orange) and red. I told her to go to ER to have it checked.
rash on hands and feet, treated with OTC diphenhydramine and topical cortisone cream
Slight fever like a 100.7; This is a spontaneous report from a contactable nurse (patient). A 76-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in Arm Left on 19Feb2021 (at the age of 76-year-old) (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history was not reported. The patient's had concomitant medications (unspecified). The patient previously first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration on an unspecified date for covid-19 immunisation. The patient experienced slight fever like a 100.7 on an unspecified date in Feb2021. The patient got the COVID-19 vaccine last day (19Feb2021), the second dose of Pfizer. And she had just a slight fever like a 100.7. She was just wondering she was just running a little bit of fever like a 100.9. The patient wanted to know if it goes higher, she can take Tylenol. Consumer was suggested to consult the healthcare provider. Consumer stated, she just cannot reach them on Saturday. The patient stated, she thinks there is a causal relationship. Outcome of the event was unknown.  No follow up attempts are possible. No further information is expected.
Pustules to back, chest, face itching.  Symptoms began 8-9 hours after injection.
Pt recvd pneumococcal vax 11MAY92 & on 12MAY92 called MD w/complaints of a sore arm & a t103 treated w/Ibuprofen (advil) & local heat; No further details were provided;
About 24 hours after my second COVID vaccine I was asleep and started having strange dreams. Woke myself up several times talking in my sleep. I woke up to chills, fever, vertigo, muscle weakness and pain, shin sensitivity on back only. A lot of pan on vaccination site. Pressure behind my eyes, fatigue.
I woke up with a swollen eye (right), nausea, and a sharp twinge in my left pinky toe.
Woke up with a small (size of a quarter) on left side of neck/shoulder (about an inch above the center of my clavicle). Lump is movable and only painful if enough pressure is applied. Also feel lump if I move my head to the right (stretch away from lump)
44 yo female with hx of pelvic congestion, s/p ovarian vein embolization on 4/12/21, no other major comorbidity had the second dose of Pfizer Vaccine  (EW0183) 15 minutes after the patient report burning sensation whole body, associated with nausea, emesis x3, and acute shortness of breath, and decline alertness, transferred to the observation room HR 160s, O2 Sat 98%, RR: 20s, Given concern for an anaphylactic reaction  * Generalized flushing And * vomiting with abdominal discomfort    EpiPen was given on left thigh BP right after EpiPen was 150s/90 Oxygen 2 liters was given  911 was called The patient was transferred to MGH with all her belongings.
Onset of the following events beginning 6 hours post injection - headache, fatigue, fever 101.2, shivering, nausea - took 500mg Tylenol  every 4 hours.  Fever began to drop after 20 hours, shivering subsided after 17 hours, headache responds to Tylenol, reduced fatigue continues at 24 hours
Breastfeeding; This spontaneous case was reported by a consumer and describes the occurrence of EXPOSURE VIA BREAST MILK (Breastfeeding) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    MEDICAL HISTORY (Parent): Concurrent medical conditions included Maternal exposure during breast feeding.    No Medical History information was reported.    On 08-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced EXPOSURE VIA BREAST MILK (Breastfeeding). At the time of the report, EXPOSURE VIA BREAST MILK (Breastfeeding) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.; Sender's Comments: This is a case of product exposure during breastfeeding with no associated AEs for this female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Within 1-2  Months of getting the Moderna Vaccines I developed Melanoma  and enlarged lymph node that waxed and waned from March 19, 2021 to September 23, 2021 when it remained enlarged. A CT dated November 2, 2021 reported a 2X3X4 cm adenopathy. The biopsy December 15, 2021 reported DLBCL recurrence. I had a Stem Cell Transplant on May 5, 2022.
Initial and thought to be normal pain and swelling.  Flue like symptoms and fever for 4 days. Pain increased to severe at 4th or 5th day.  Deep, extreme & worsening muscle pain and joint pain.  Apparent attrition of muscle tissue.  Severe loss of range of motion.  Surface skin tissue tenderness and pain at point of injection plus 3" diameter circle.
Information has been received from a consumer concerning her daughter with no known drug reactions/allergies and medical history reported who on an unspecified dates was vaccinated with the first, second and third doses of GARDASIL. The reporter stated that on unspecified dates, her daughter experienced dizziness, flu-like symptoms, 102 degree fever and is having problems with clotting after receiving GARDASIL. These adverse experiences happened after every dose of GARDASIL. It was unknown if the patient sought medical attention. Additional information is not expected.
The vaccine hurts; couldn't lift arm; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in a 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 pain (Verbatim: The vaccine hurts) and mobility decreased (Verbatim: couldn't lift arm). The outcome of the pain and mobility decreased were not reported.   It was unknown if the reporter considered the pain and mobility decreased to be related to Shingles vaccine.     It was unknown if the company considered the pain and mobility decreased to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 30-APR-2023 This case was reported by the patient via interactive digital media. The patient received a dose of Shingles vaccine and reported that the vaccine hurt, and his/her arm felt he/she could not lift it. The patient reported that, okay but the disease was worse and reported that the vaccine protected them and stated that they have to get the second as well.  Follow-up would not possible, as no contact details were available.
Received 2nd Pfizer vax 02/03/2021 dose: EL9263.  Stroke 02/10/2021 morning.  Couldn't move my right arm where I wanted and right arm weakness for 2 days.  No problem after 3rd day. Hospitalized same day.3 blood clots on brain.  Brain scan, ultrasound from ankles to neck.  Scoped the back of heart looking for blood pooling.  CT scan.
The patient received Moderna COVID-19  bivalent vaccine that underwent a temperature excursion; No adverse event; The patient received Moderna COVID-19  bivalent vaccine that underwent a temperature excursion; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (The patient received Moderna COVID-19  bivalent vaccine that underwent a temperature excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (The patient received Moderna COVID-19  bivalent vaccine that underwent a temperature excursion) and NO ADVERSE EVENT (No adverse event) in a 49-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 057F22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 30-Nov-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 30-Nov-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (The patient received Moderna COVID-19  bivalent vaccine that underwent a temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (The patient received Moderna COVID-19  bivalent vaccine that underwent a temperature excursion) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (The patient received Moderna COVID-19  bivalent vaccine that underwent a temperature excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (The patient received Moderna COVID-19  bivalent vaccine that underwent a temperature excursion) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (The patient received Moderna COVID-19  bivalent vaccine that underwent a temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (The patient received Moderna COVID-19  bivalent vaccine that underwent a temperature excursion).    No concomitant medications were reported.  It was reported that Proposed desired Use by Date was 05-Dec-2022. Two unbroken cartons of Bivalent vaccine was stored in frozen condition at the time of excursion. The vial had reached 11.5 degrees Fahrenheit for 1 hour 18 minutes. There was a little bit of frost on the brim or neck of all of the vaccine vials. Now the vials were quarantined in the freezer and labeled not for patient use. No other adverse events reported.  No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-681480, US-MODERNATX, INC.-MOD-2022-681490 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-681480:patient 2 (Bivalent case) US-MODERNATX, INC.-MOD-2022-681490:Monovalent case
Positive rapid antigen test for COVID19 with mild cold symptoms & fatigue 5 days
This spontaneous report as received from a certified medical assistant via a company representative, refers to an unspecified number of patients of unknown age and genders. No information on their medical history, concurrent conditions or concomitant drugs was provided. On an unknown dates the patients was vaccinated with ROTATEQ which was improperly stored (doses, administration sites and routes, lot# and expiration dates were not reported). This is one of several reports from the same reporter. Additional information has been requested.
Rash and hives, itching at site of Meningitis vaccine administered on 4/24/12. Given BENADRYL by parent.
Painful swelling, reddened, warm to touch lt deltoid; cold packs to area; APAP for fever or discomfort; pt moving w/go to ER there if needed; seen by MD ped clinic;
administered 3 days after expiration; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 18-year-old female patient who received Men B NVS (Bexsero) (batch number ABXB34AA, expiry date 31st July 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 3rd August 2022, the patient received the 1st dose of Bexsero and Bexsero Pre-Filled Syringe Device. On 3rd August 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe 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: 12-Aug-2022 Reporter's comment: The clinic manager stated that Bexsero was administered to a patient 3 days after the expiration date. The reporter consented to follow-up via postal. Additional supportive information: The patient received an expired dose of Bexsero, which led to expired vaccine used. The case was linked with case US2022118576, reported by same reporter for different patient.; Sender's Comments:  US-GSK-US2022118575:Same reporter
COVID vaccine arm - redness, swelling, soreness, itching, 4-5? diameter. Center of swelling 4? south of injection site.
Same evening, 3/6 at about 2000 hours, got cold chills and the shakes. Felt exhausted and all muscles ached. The next morning 3/7 at approximately 0830, same effects as previous, but also a horrible migraine and vomiting. Took one 6ml injection Sumatriptan for migraine in opposite arm from Covid vax, no effect and no relief. 1300 hours, migraine was so intense, I advised my wife I would do a 2nd Sumatriptan injection and if it didn't work, I would need to be brought to the emergency room. 2nd injection was successful in relieving migraine approx 45 min after injection. Felt run down, but was able to go to work the next morning 3/8. Felt tired and run down on 3/8, but symptoms went away by late evening. This was surprising, since my first Covid vax dose 4 weeks prior didn't affect me as bad as this 2nd dose
I started to feel  pain in my chest Thursday night only about 5 hours after the vaccine was given.  Both of my breast became enlarged and extremely painful. I waited 3 days and contacted my OBGYN for an appointment.  After being seen I was told yes my breast are swollen but no lumps were noted. I was sent home to watch and wait to see if it resolves. I am 7 days post vaccine and still having pain and enlarged breast.
Hives 20 minutes after injection. Throat tightness within an hour, severe coughing.
shortness of breath, light headed/dizziness, tingling of lips and tongue, felt as if tongue swelling, difficulty swallowing and speaking, nausea, numbness of lips
Pt has redness locally @ injection site of right arm where Kinrix was given and right arm where varicella was given with slight swelling and warmth.  Mother provided child with Tylenol and Benadryl and ice pack. Child had no fever, nausea, vomiting, or any other adverse signs.
Mom came back to clinic room for nurse to see child, dark red splotches around mouth,c/o itching around mouth,was able to talk&no SOB noted.Tongue was not swollen,told to stay 10 mins,during that time the redness faded.Rash came back-to ER.
Information has been received from a pharmacist concerning a pt who  was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine intradermally and developed a "nasty site reaction". Unspecified medial attention was sought. There was no product quality complaint involved. Additional information has been requested.
Pt. reaction to second SHINGRIX vaccination, fever, bp increased, pulse oxygen down, headache, loss of appetite, breathing, heart racing, face, hands, feet swelling, body pain, asthma flare up. Saw MD. Gave steroid injection and prednisone by mouth. OK now.
About 3 weeks ago, I began to notice that coffee smelled odd. Since then, my sense of taste and smell have increasingly worsened to the point that I am extremely nauseated.  It is awful.
ELEVATED LIVER ENZYMES/LIVER ENZYMES RAISED; HEARTBURN; HEART ERYTHEMA; PAIN ALL OVER; SORE ARM; This spontaneous case was reported by a consumer and describes the occurrence of HEPATIC ENZYME INCREASED (ELEVATED LIVER ENZYMES/LIVER ENZYMES RAISED), DYSPEPSIA (HEARTBURN), ERYTHEMA (HEART ERYTHEMA), PAIN (PAIN ALL OVER) and VACCINATION SITE PAIN (SORE ARM) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. On an unknown date, UPADACITINIB (RINVOQ) (Oral) dosage was changed to at an unspecified dose. In 2021, the patient experienced PAIN (PAIN ALL OVER) and VACCINATION SITE PAIN (SORE ARM). On an unknown date, the patient experienced HEPATIC ENZYME INCREASED (ELEVATED LIVER ENZYMES/LIVER ENZYMES RAISED), DYSPEPSIA (HEARTBURN) and ERYTHEMA (HEART ERYTHEMA). At the time of the report, HEPATIC ENZYME INCREASED (ELEVATED LIVER ENZYMES/LIVER ENZYMES RAISED), DYSPEPSIA (HEARTBURN) and ERYTHEMA (HEART ERYTHEMA) had not resolved and PAIN (PAIN ALL OVER) and VACCINATION SITE PAIN (SORE ARM) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Hepatic enzyme: ELEVATED.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.   The reporter's causality for the events of elevated liver enzymes/liver enzymes raised and heartburn with rinvoq(upadacitinib) was a reasonable possibility. The reporter's causality for the events of heart erythema, first covid 19 injection had sore arm with rinvoq(upadacitinib) was no reasonable possibility. The reporter's causality for the event of pain all over was not provided.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No treatment information was provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   This case was linked to MOD-2021-624363 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-Feb-2022: Significant follow up received included event information, reporter opinion of causality, suspect drug information and narrative description updated.
1500pm  Itching and hives to bilateral extremities and face.  15:05pm 5ml of benedryl given po.  30 minutes after taking Pfizer, Alert and oriented x3, Resp. even/unlabored. HRR, Lungs clear, Ambulatory.  No acute distress.  15:15pm 150/80 67 20  O2 94%;  15:27pm  120/80 63 16  O2 95%;
No problems initially.  9 to 10 days post vaccine  site started to itch. Looked like a mosquito bite for a couple days.  by day 3 was the diameter of a softball.  Itchy, red and warm to touch.
little uncomfortable for a day; This is a spontaneous report from a contactable consumer (patient). A 72-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection; Batch/Lot number and Expiration Date was not reported), via an unspecified route of administration on an 31Jan2021, as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced little uncomfortable for a day on an unspecified date. The outcome of event was recovered on an unspecified date.  No follow up attempts are possible. Information about lot/ batch number cannot be obtained. No further information is expected.
consumer only received the "diluent" portion of the Shingrix vaccine #1; consumer only received the "diluent" portion of the Shingrix vaccine #1; This case was reported by a consumer via call center representative and described the occurrence of inappropriate preparation of medication in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, 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.  Additional details were reported as follows: The case was reported by the patient's friend, as the patient was not available. The age at vaccination was not reported. The patient received only diluent portion of the Shingrix vaccine, which led to  inappropriate preparation of medication and inappropriate dose of vaccine administered. The physician's office notified and rescheduled the patient to return in 4 weeks for the complete Shingrix vaccine. The reporter did not want to give any other information. The reporter did not consent to follow up.
At 15 minutes developed abdominal pain, facial redness, heat and burning. Lasted 2 hours and self abated. On day 4 developed new onset food and flower allergies which lasted until day 10. These were lip tingling, eye swelling and redness and burning.
Pruritic rash developed around site of injection and radiated to distal arm. Also complained of generalized pruritis. Treated with oral Diphenhydramine 25 mg PO.
This spontaneous report as received from a registered nurse refers to a 2 patients of unknown age and gender. In an approximately 2014 (reported as recently, exact date not provided), 2 patients were vaccinated with a dose of improperly stored ZOSTAVAX (lot number, expiration date, dose and route were not reported). No adverse effects were reported. Additional information has been requested.