chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Very sore; Immediately hot at the injection site; Patient under 65 received Fluad QIV; This spontaneous case received on 05-Nov-2020 from other health professional (nurse) via Agency (reference number: SEQW20-04783) and concerned a 41-year-old, female patient.   The patient had no relevant medical history. The patient's concomitant medications were not reported.   On 29-Sep-2020, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, MF59, dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid) (explicitly coded as 'Inappropriate age at vaccine administration') for influenza prophylaxis. The batch number reported was 286592.   On the same day, immediately after receiving Fluad Quadrivalent, the patient felt very sore and hot at the injection site. The patient did not receive any corrective treatment.  The outcome of the events was not reported.  The reporter did not provide a causality assessment.  The case was assessed as non-serious.  The case is linked to the cases 202004845, 202006068, 202006069, 202006072, 202006074, 202006077, 202006080, 202006084, 202006085, 202006086, 202006087, 202006089, 202006090, 202006091, 202006092, 202006095, 202006097 and 202006098 (the same reporter).  Company comment: A 41-year-old, female patient was vaccinated with Fluad Quadrivalent. On the same day, immediately after receiving Fluad Quadrivalent, the patient developed pain and vaccination site warmth. With information available, causal role of the suspect vaccine is assessed as possibly related. Product administered to patient of inappropriate age is assessed as not related, per company's conventions.; Sender's Comments: A 41-year-old, female patient was vaccinated with Fluad Quadrivalent. On the same day, immediately after receiving Fluad Quadrivalent, the patient developed pain and vaccination site warmth. With information available, causal role of the suspect vaccine is assessed as possibly related. Product administered to patient of inappropriate age is assessed as not related, per company's conventions.
Increasing soreness, swelling, redness, fever up to 100.8, called MD.  Appointment 01/08/04 given ABO.
This spontaneous report was received from a healthcare worker referring to a patient of unknown age and gender. The patient's pertinent medical history and drug reactions/allergies were not reported. On 27-JAN-2016, the patient was vaccinated with a dose of ROTATEQ (lot # L013192 and expiration date January 2017, oral), which was exposed to temperatures outside of the recommended range. There were no concomitant medications provided. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Information has been received from a licensed practical nurse concerning a 20 year old female with a penicillin allergy and no pertinent medical history who on 15-MAY-2007 was vaccinated with a first dose of Gardasil (lot# 653736/0014U) 0.5mL IM. Concomitant therapy included NUVARING. On 15-MAY-2007 the patient developed a fever of 101.6 degrees F shortly after the dose was administered. Medical attention was not sought. The fever subsided by the time the patient woke up the following morning on 16-MAY-2007. At the time of reporting the patient recovered. No further information is available. Additional information has been requested.
taste was off. Lemonade smelled like gas, and tasted like it sat for a month. Blueberries tasted like mold; Feet and toes turned black and blue; Lemonade smelled like gas; Didn't feel like eating; Didn't feel well; Tingling from left knee down leg; Acute iron deficiency; fever of 104 F but then temperature back down to 99 F; This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (taste was off. Lemonade smelled like gas, and tasted like it sat for a month. Blueberries tasted like mold), SKIN DISCOLOURATION (Feet and toes turned black and blue), ANOSMIA (Lemonade smelled like gas), DECREASED APPETITE (Didn't feel like eating) and MALAISE (Didn't feel well) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 16B21A and 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Heart valve replacement NOS (mechanical heart valve).   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced AGEUSIA (taste was off. Lemonade smelled like gas, and tasted like it sat for a month. Blueberries tasted like mold), SKIN DISCOLOURATION (Feet and toes turned black and blue), ANOSMIA (Lemonade smelled like gas), DECREASED APPETITE (Didn't feel like eating), MALAISE (Didn't feel well), PARAESTHESIA (Tingling from left knee down leg), IRON DEFICIENCY (Acute iron deficiency) and PYREXIA (fever of 104 F but then temperature back down to 99 F). At the time of the report, AGEUSIA (taste was off. Lemonade smelled like gas, and tasted like it sat for a month. Blueberries tasted like mold), SKIN DISCOLOURATION (Feet and toes turned black and blue), ANOSMIA (Lemonade smelled like gas), DECREASED APPETITE (Didn't feel like eating), MALAISE (Didn't feel well), PARAESTHESIA (Tingling from left knee down leg) and IRON DEFICIENCY (Acute iron deficiency) outcome was unknown and PYREXIA (fever of 104 F but then temperature back down to 99 F) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 104 (High) 104 degree Fahrenheit and 99 (normal) 99 degree Fahrenheit.         The action taken for mRNA-1273  Moderna COVID -19 vaccine was not applicable. Patient stated that  concomitant medication  are taken( didn't not specify which).  No Treatment medication was provided.  Patient had gone to ER 30MAR2021.   This case was linked to US-MODERNATX, INC.-MOD-2021-065322 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 21-Jun-2021: New event added acute iron deficiency having out come unknown.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-065322:1st dose case
Caller is an 89 YOF that received her 2nd COVID 19 Vaccine, Pfizer BioNTech, on 12-FEB-2021.  This was on a friday afternoon and patient started to develop itching to site on Monday, exact time unknown.  She has not taken any medications for this and normally does not taken any medications as she has DM and is concerned about any interaction medications may have with the DZ.  Pt has used an ice pack to the site.  Patient states that itching has gotten much better but she still feels that it is hot to the touch.  no inflammation or rednesness reported to site.    Center adv would make a note of the s/s reported.  adv if area of discomfort/heat to touch gets worse, seek medical attention.  Center attempted to ascertain if s/s could be infx to site but pt denies further involvement.  adv to contiue to monitor for s/s to site and PIC w/f/u.  Adv that if s/s persist she may use OTC meds like antihistamine/analgesics for relief.  adv to call back if any questions.
Chronic headache pain. 2/18/09MR received from PCP including vax rec and numerous consultations. Initially c/o with visual changes 10/3/07. PE (+) for R posteriar auricular node. Dx: Lymphadenopathy.  Multiple OVs 1/2008-1/2009  for H/A with increasing freqeuncy and severity. Occur daily with blurry vision. Dx:  Chronic H/A, Migraine. Back and leg pain noted 1/29/08 with photophobia. Sinusitis with Sinus surgery 4/08 and  5/08. Nothing helping H/A pain by 12/08 despite Botox, steroids and analgesics.DX:  Intractable H/A pain. Depression and Anxiety noted 1/20/09. Multiple consults beginning 2/2008. ENT consult-severe cephalgia-out of proportion with sinus disease. ? Migraine.  Neuro consult 2/26/08 -H/A- multifactorial. F/U 8/25/08. Recent psych admission for Major Depressive Episode with med adjustment. Pain mgmt consult 10/3/08 for constant H/A. Chronic Daily H/A with tension-type H/A features and occipital neuralgia. Occipital nerve blocks helped temporarily. Multiple F/Us. Scalp muscles possibble as source of pain.  Accupucture started 2/09.
LT deltoid red, warm to touch, swollen 2 inch in length, 1 3/4 in width.
Right side of half of face to arm went numb, and a burning chest. Trial of cyclobenzaprine and to follow up with PCP
Pt presented in ER on 7 and 18 Aug'14 for spreading skin lesions that she developed after her primary SPV given 30 Jul'14. Pictures sent and was determined to have erythema multiforme minor. Given oral steroids and medical exemption to SPV.
The day of the 7/8 vaccination the patient developed chills.  On 7/9 the patient then developed a retro-orbital headache with fevers, chills, and myalgias.  These symptoms persisted and on 7/10 the patient then developed chest pain, prompting presentation to the ED with subsequent admission.
WIFE CAME TO STORE ON 4/26 AND INFORMED US THAT HER HUSBAND HAD BEEN VACCINATED WITH HIS FIRST MODERNA COVID DOSE ON 4/17.  HE WAS FINE AFTERWARDS BUT DEVELOPED AN ITCHY RASH FROM THE NECK DOWN ON THE EVENING OF 4/18.  HE DID NOT COMPLAIN OF ANY OTHER SYMPTOMS AND DID NOT TAKE ANY MEDICATION FOR THE RASH.  SHE STATED THAT HE TOOK A COLD SHOWER AND THE FOLLOWING MORNING THE RASH WAS COMPLETELY GONE
over 45years of age was administered a first Gardasil 9 dose; no additional AE; This spontaneous report was received from a pharmacist and a pharmacy intern and refers to a patient of unknown gender, who was over 45 years of age. There was no information regarding their medical history, current conditions nor concomitant therapies provided.  On an unspecified date, the patient was vaccinated with the first dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (exact dose, route of administration, anatomical location, lot # and expiration date were not provided) for prophylaxis (inappropriate age at vaccine administration). No adverse event (AE) was reported.  The pharmacist requested the vaccine medical information, however did not had supervisor's permission to be contacted regarding the event.
This spontaneous report as received from a health professional refers to unspecified patients of unknown age and gender. On an unknown date the unspecified patients might had vaccinated with improperly stored M-M-R II (lot#, dose, frequency and route unspecified), which were exposed to 53F for 12 hours and M-M-R II (lot#, dose, frequency and route unspecified), which were exposed to 54F for five hours. No adverse effects reported. Additional information has been requested.
Hard swelling & heat, 2" diameter circle, at injection site, low-grade fever, malaise.
Received 2nd dose Pfizer Lot EL0142 in right arm. About 15 minutes after receiving dose, she started to develop itch in right forearm and nose
Received intramuscular injection of flu vaccine in left deltoid at 8PM at night.  Per mom almost immediately began complaining of hurt.  Per mom client continues to hurt even though daughter active - skiing, swimming, shoveling snow.  Has not given any Tylenol or Motrin.  Mom reports increased pain by touching the corner where shoulder and arm meet, has not seen doctor.  Advised needed to follow up with doctor and to call for diagnosis and  recommendations.
This case was reported by a pharmacist via another manufacturer and described the occurrence of allergic reaction in a subject of unspecified age and gender who was vaccinated with ENGERIX B (GlaxoSmithKline). On an unspecified date the subject received a dose of ENGERIX B (unknown details). At an unspecified time after vaccination with ENGERIX B, the subject experienced allergic reaction (described as "unspecified allergic"). No additional details were provided. At the time of reporting the outcome of the event was unspecified.
On Oct. 12, clubs received an internal Urgent Removal Notice regarding Pfizer COVID-19 Vaccine- 5-11 Years Tris-sucrose, Lot #FL2757 with manufacturer?s expiration date of Sept. 30.  Information has been received from the manufacturer indicating that stability data supports the use of this product through Oct. 19.   This was administered 10/8
Patient received Comirnaty but form won't let me move on without putting this in.    Patient developed 6 full blisters a day after vaccine right where vaccine was given on right arm. No other Symptoms. They became itchy and kept refilling the following day. Was instructed to take Benadryl and put on topical steroids.
She reports being in good health until receiving her ANA injections.  "I had problems after every shot".  Her symptoms following each injection are listed below.  Small nickel size tender nodule at site of injection.  It resolved in 2 days.  Developed generalized, dull headache approximately 4/10 on pain scale that began within 1/2 hour of receiving the vaccine without photophobia or Paresthesia, that persisted "off and on" for a period of 4 days.  She self medicated with ASA and Excedrin with some easing of the pain, but not complete resolution. Also complained of upset stomach, drowsiness and feeling fatigue "like I needed a nap-but I'd wake up still feeling tired".  Her fatigue however did not affect her ability to perform her duties. ANA #2, same adverse events as #1 Nausea and vomiting x 2 during the next 24 hours.
Slight pain at the injection site; Headache; Mild fever; Extreme tenderness of arm starting about 2" below the injection site and extending about 4" toward the elbow; Rash; This case was reported by a consumer and described the occurrence of injection site pain in a 77-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included methotrexate and infliximab (Remicade).   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced injection site pain, headache, fever, tenderness and rash. On an unknown date, the outcome of the injection site pain, headache, fever, tenderness and rash were unknown.   It was unknown if the reporter considered the injection site pain, headache, fever, tenderness and rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported, however the patient could be 77 or 76 years old at time of vaccination. The patient had a few symptoms or reaction some of which are listed as possible reactions and a couple of which do not see noted. The patient stated that the ones that are apparently common are very slight pain at the injection site, headache and mild fever 100.8. The unexpected reactions include extreme tenderness of my arm starting about 2 inch below the injection site and extending about 4 inch toward the elbow with a rash appearing in this. The tendered was sufficient than the patient cannot lay on that side. The patient just wanted to check this out as do not know anyone else who has experienced these symptoms and have not seen them listed anywhere.      Lab Comments: On unknown date, body temperature was 100.8
This spontaneous prospective pregnancy report has been received from a registered nurse referring to a 23 year old female patient with penicillin allergy and rhesus antibodies (RH) negative. On 31-MAR-2015 the patient was inadvertently received a dose of GARDASIL (lot # K009482, expiration date; 06-MAR-2017, 0.5 ml, intramuscular) instead of Tdap, while pregnant at 27 weeks and 5 days. The last menstrual period (LMP) was 19-SEP-2014 and the estimated date of delivery (EDD) was 26-JUN-2015. Concomitant therapies included RHOGAM and Tdap. The patient visited the office, it was determined that the patient was having contractions and she was sent to hospital on 31-MAR-2015. No lab diagnostics studies were performed. The patient was monitored and discharged to home on 31-MAR-2015. On 01-APR-2015, the patient was sent back to the hospital (reason unspecified). At the time of the report the outcome of adverse events was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Client had a syncope episode seconds after receiving the last injection (HPV) while still in the chair. Client was reclined in the chair. Client was pale during spell. Syncope last about five seconds. She denied nausea and no emesis. Client's V/S were B/P108/58, pulse 72, and Respirations 20. Client was then moved to a sitting position after 10 min and did well, stated feeling better. After 5 more minutes in the sitting position she was asked to stand and tolerated well. Client was asked to be in observation in waiting area for 15 min. 3:05 while in waiting area she became pale again V/S B/P108/58, Pulse72, and Resp 20. Client was layed down for 15 min and recovered.
Shingles breakout occurred one month after receiving second Covid-19 shot.   Rash developed on May 31, 2021.
terrible headache; on and off nausea; her arm kept getting fever; more of a weird headache like a fog that she can't get rid of; The redness keeps getting bigger and is around the shoulder now; arm started to feel like someone punched her; her arm felt like it was on fire; had a red feverish big lump on it; Little bit of soreness the next day; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Little bit of soreness the next day), LIMB DISCOMFORT (arm started to feel like someone punched her), FEELING HOT (her arm felt like it was on fire), VACCINATION SITE MASS (had a red feverish big lump on it) and HEADACHE (terrible headache) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COPD (COPD with emphysema) and Emphysema (uses nocturnal oxygen). Concomitant products included VENLAFAXINE HYDROCHLORIDE (EFFEXOR), GABAPENTIN, ROSUVASTATIN, ASPIRIN [ACETYLSALICYLIC ACID], CALCIUM, OMEPRAZOLE and ALPRAZOLAM (XANAX) for an unknown indication.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, the patient experienced MYALGIA (Little bit of soreness the next day). On 26-Mar-2021, the patient experienced LIMB DISCOMFORT (arm started to feel like someone punched her), FEELING HOT (her arm felt like it was on fire) and VACCINATION SITE MASS (had a red feverish big lump on it). On 27-Mar-2021, the patient experienced HEADACHE (terrible headache), NAUSEA (on and off nausea), VACCINATION SITE WARMTH (her arm kept getting fever), FEELING ABNORMAL (more of a weird headache like a fog that she can't get rid of) and ERYTHEMA (The redness keeps getting bigger and is around the shoulder now). On 20-Mar-2021, MYALGIA (Little bit of soreness the next day) had resolved. At the time of the report, LIMB DISCOMFORT (arm started to feel like someone punched her), FEELING HOT (her arm felt like it was on fire), VACCINATION SITE MASS (had a red feverish big lump on it), HEADACHE (terrible headache), NAUSEA (on and off nausea), VACCINATION SITE WARMTH (her arm kept getting fever), FEELING ABNORMAL (more of a weird headache like a fog that she can't get rid of) and ERYTHEMA (The redness keeps getting bigger and is around the shoulder now) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information included tried ice, cool compress, tylenol, neosporin, benadryl cream with little relief.
Laid down for nap: flushed temp 102.7. Highest 103.5: lasted for 3 days up and down. Leg not swollen: lethargic, wanted to be cuddled, appetite decreased. Drank liquids. Used Motrin prn.
Right sided headache x 5 days.  No thunderclap onset. Patient complains of nausea and sensitivity to light.  Headache is throbbing in nature.  Patient experienced tingling in right cheek the day before presentation. Patient is treated with diphenhydramine and prochlorperazine in ER and is given a prescription for Topamax to take at home for the next 5 days.
Pain in injection site, large knot at injection site, & numbness in (L) arm & (L) hand & cramping of (L) hand.
throat clearing; shortness ofbreath; Difficulty breathing; Throat tightness; This is a spontaneous report received from a non-contactable Healthcare Professional. A 34-years old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot number: EN6207), via an unspecified route of administration on 18Mar2021 (at the age of 34-year old) as dose 1, single for COVID-19 immunisation. Medical history and concomitant medications were not reported. On 18Mar2021, during his 15-minute waiting period after the injection, the patient began to experience difficulty breathing and throat tightness. Patient denied rash, hives, welts, difficulty swallowing, throat tightness, hoarseness, stridor, itching, light-headedness, dizziness, facial swelling, lip swelling and tongue swelling. Patient complains of frequent throat clearing and shortness of breath. Treatment included water. It was reported that the patient discharged, stable to go home and follow up with PCP. The clinical outcome of the events difficulty breathing and throat tightness, frequent throat clearing and shortness of breath was unknown at the time of reporting.   No follow-up attempts are possible. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: 1. Patient Country added. 2. The denied events were deleted from event tab. 3. Lead sentence updated as This is a spontaneous report received from a non-contactable Healthcare Professional. 4. Final sentence updated as No follow-up attempts are possible. No further information is expected. 5. Narrative removed sentence 'The events did not resulted in Doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care.' since not reported on source.
REDNESS,SWELLING AND PAIN AT INJECTION SITE FOR MORE THAN 1 WEEK. NOW SHE IS FINE. SHE HAD NO TREATMENT. SHE ONLY CALLED THE DOCTOR OFFICE NOT A VISIT.