chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Case number PHEH2013US015036 is an initial spontaneous report received from a medical assistant on 12 Jul 2013, and with a follow up report received on 06 Aug 2013: This report refers to a 12 year old male child. His medical history was not reported. Concomitant medication included FORMITEX. He was given only the Men A component of MENVEO (batch number: X12118) intramuscularly on 11 Jul 2013. MenA was reconstituted with water instead of MenCYW-135. He was instructed to revaccinate with both the components. No adverse event was reported following this administration error. Follow up report received on 06 Aug 2013. Updated concomitant drug.
Fainted, history of same symptom.  No acute distress  BP 95/53 ; 103/54 HR: 76 Sp02: 95%  Seen and cleared by EMS
Lump and soreness to left arm, loss sense of smell Narrative:  Other Relevant History:
Swollen (L) deltoid, warm to touch. Tx Benadryl.
Approximately 9 days following vaccine administration  raised red,  itchy  bumps appeared on the backs of hands, wrists, and elbows. The following day my fingers were sore. Three hours later red bumps erupted on my fingers and palms. Three days following the initial bumps, more bumps appeared on the bottom and tops of toes. Hydrocortisone cream and Benadryl provide minimal relief. The bumps continue to appear 16 days following  administration. The bumps are comparable to the bumps I experience when taking amoxicillin following Epstein Barr virus.
Error identified within 1 hour of administration of incorrect vaccine ZOSTAVAX rather than VARIVAX to a pediatric patient. No reactions as of now per mom.
Day after receiving the shot, my entire body broke out in a red rash.  It cleared up within eight hours. On the third day, the rash resurfaced  but dissipated after five hours.
eczema; Initial information received on 17-Feb-2021 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves female patient of an unknown age who experienced eczema, while she received vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL].  Medical history, medical treatment, vaccination and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) for Immunisation; and ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) for Immunisation.  On an unknown date, the patient received a standard dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot UJ191AAA and expiry date: 22-Feb-2022) via an unknown route in the left thigh for prophylactic vaccination.  On an unknown date, the patient developed a non-serious eczema (unknown latency) following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE.  Details of laboratory data not reported.   It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome of event was reported as unknown.
Vomiting and inability to eat or retain food, swollen/painful arm lasting 4 days, hard welt/ball like swelling at peak of swelling beginning Thursday evening through Saturday, inability to raise, hold, grasp or use arm for 2 days after injection, consistent fever for 36 hours/intermittent fever through Saturday, tightness in chest (relieved with inhaler every 2 hours) for 36 hours, tingling  and phantom pain along left side of body and face, excessive exhaustion, dizziness and  unfocused thoughts 48 hours, persistent migraine for 36 hours, intermittent headaches continuing with chills  and nausea. Worse symptoms were 24-72 hours after injection,  more mild side-effects (intermittent headache, nausea and chills) continuing through today.
Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Systemic: bleeding-Severe, Additional Details: patient bleed and was sqirting out of her arm for 1 second and was covered with cotton swab and resolved. patient waited in vaccine area for 15 min and felt well with no issues.
This case was reported by a physician via call center representative and described the occurrence of localized skin reaction in an adult female patient who received SHINGRIX. On 20th April 2018, the patient received the 1st dose of SHINGRIX. In April 2018, less than a week after receiving SHINGRIX, the patient experienced localized skin reaction, pruritus and pain. On an unknown date, the outcome of the localized skin reaction, pruritus and pain were recovering/resolving. It was unknown if the reporter considered the localized skin reaction, pruritus and pain to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient's husband. The age at vaccination was not reported. Over the next four days after receiving SHINGRIX, the patient experienced a large painful and pruritic local reaction which reached a final size of 3 by 5 cm. At the time of this reporting, it was starting to abate. The reporter was asking whether she should receive the 2nd dose and should any precautions be taken.
Approx. 16 days after my Covid-19 shot, I began hearing loud ringing in both ears that doesn't go away. It has continued and doesn't stop. Volume fluctuates. Sounds like crickets or an electronic hum/buzz sound. Very disturbing and it's hard to concentrate and hard to sleep. The research I've done indicates this is Tinnitus.  I don't know yet if this is permanent.
Narrative: COVID infection following COVID vaccine series 04/22, SINOVAC, dose #1 (NON FACILITY) 05/20, SINOVAC, dose #2(NON VACILITY) 01/02 COVID swab, result: detected 01/03 COVID sab, result: detected 01/02 pt cc: mild cough, Rhinorrhea, and sore throat exposure: unknown 01/03 pt admit ED cc: mild cough, Rhinorrhea and sore throat dx: COVID+ LOS: 1 day  01/30/2021 date of death 1/30/2022
pt recvd vax; redness, swelling, itching at site, dose 2; lasted x 5 days;
Two hours post vax the patient started crying and high pitched screaming. The patient cried for 10 straight hours and could not be consoled. The patients legs swelled for 9 days, she ran a fever of 99-101F for 5 days, and did not return to being "herself" for 1 month.
Shoulder pain in arm where vaccination was given. Unable to move arm for 2-3 days. Steriod treatment was started and relieved the pain, but a tingling of the arm and fingers still exists.
This spontaneous report as received from a physician refers to a 42 year old male patient. Patient's pertinent medical history, previous drug reactions/allergies and concomitant medication were reported as none. The patient had an unspecified titer test in 2008 and the results were negative. On 24-AUG-2016, the patient was vaccinated with VARIVAX (strength, dosing details, anatomical location, lot# and expiration date were unknown). The reporting physician did not vaccinate the patient. About 2 weeks later (unknown date in SEP-2016), the patient experienced significant irritation, redness and bumps which were itchy on both posterior legs and back of thighs. The rash resolved after 2 weeks. The reporting physician did not see the rash and felt that it was a non varicella rash. A second titer was performed and the results were negative. No treatment was given for the adverse event. The outcome of rash was reported as resolved and the rest of the events outcome was unknown. Causality assessment was not provided. No product quality complaint was involved. Additional information has been requested.
Pneumonia; This case was reported by a consumer via patient support programs and described the occurrence of pneumonia in a adult female patient who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received Bexsero at an unknown dose. On an unknown date, unknown after receiving Bexsero, the patient experienced pneumonia (serious criteria GSK medically significant). On an unknown date, the outcome of the pneumonia was unknown.   It was unknown if the reporter considered the pneumonia to be related to Bexsero.  Additional information was provided as follows: The age at vaccination was not reported. The patient received Bexsero in 2013 or 2014 and had pneumonia.
C/o dizziness, nausea and itching throat 10 minutes after vaccination.  Patient given Zofran 4 mg oral w/o improvement.  Symptoms improved over 40 minutes.  Received ride home from brother.
Sporadic hives on face, bottom, arms, legs x 4 days. 1 week after injection, site became warm, red, and hard.
Patient's mother called and told us that the patient started showing symptoms of and had been diagnosed by a physician with Pseudobulbar Affect. His symptoms started on 5-20-21 and include jerky motions and uncontrollable laughter. She said he can't control his laughter and laughs non-stop at night.
He got a pretty sore arm; Woke up with a severe headache; Muscle ache; Joint pain; Fever; This is a spontaneous report from a contactable nurse. The nurse reported for her husband. A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: EL9264 and expiry date were reported as unknown) via an unspecified route of administration on 02Feb2021 at 07:12 as a single dose for COVID-19 immunization. Medical history included COVID-19 from 20Nov2020 to an unknown date. The patient's concomitant medications were not reported. On an unspecified date in Feb2021 the patient experienced pretty sore arm and in midnight he woke up with severe headache, muscle ache, joint pain and fever. No further information could be pro probed as the consumer already filled out the report online and was not willing to file the safety report again. Limited information available on the call. The outcome of all the events was unknown.  Follow-up attempts are completed. No further information is expected.
Patient woke up the next morning with redness between the injection site on the left arm and the elbow. She went to see her doctor who diagnosed her with cellulitis and prescribed an antibiotic to take for 10 days. She states that her arm is also sore.
No additional adverse events reported; administration of expired PROQUAD to patient; vaccine experienced previous temperature excursion; This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 12-APR-2021, the patient was vaccinated with an expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (route of administration and anatomical location were not reported) lot # S031881, expiration date: 07-APR-2021, 0.5 ml for prophylaxis.  Administered dose of vaccine underwent previous temperature excursion of 4.7 degrees Celsius for 36 hours on 14-FEB-2021. Digital data logger was involved. No additional adverse events were reported.
4-6 hrs after administration; injection site became red, knot. Erythema began to spread 5/25/06 and has continued to spread (10-15cm). Site is warm, non-tender, hard but no induration or fluctuance.
Swelling of left upper arm, painful and warm to the touch. Parents noticed swelling on next day 5/15 around 6pm. Mom also noticed hives on 5/15/, around 6pm.
DAPTACEL and Infanrix were both administered with no reported adverse event; Initial information received on 23-Nov-2022 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves a 1 years old and unknown gender patient who had daptacel and infanrix were both administered with no reported adverse event while receiving vaccines infanrix and diphtheria-15/tetanus/5 ac pertussis vaccine [Daptacel].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.    On an unknown date, the patient received suspect diphtheria-15/tetanus/5 ac pertussis vaccine and infanrix not produced by Sanofi Pasteur (dose, strength, frequency, formulation, route, batch number, expiry date: unknown) in unknown administration site for unknown indication (immunization).  On 08-NOV-2022 the patient was diagnosed with non-serious event of daptacel and infanrix were both administered with no reported adverse event (overdose) (unknown latency) following the administration of diphtheria-15/tetanus/5 ac pertussis vaccine and (unknown latency) following the administration of infanrix.  Action taken was not applicable.  Outcome was Unknown
Pt received her first pfizer covid vaccine at 1519 in R delt. Approx 9 minutes later patient began having a seizure. Patient's 3 children were present and getting their vaccine that day as well. They informed staff she had a history of seizures. Patient was moved from chair to the ground in a laying position on her left side. RN was called immediately into the room. Her first seizure was approx 6 minutes long and the shortest was 45 seconds. Patient had 4 seizures in approximately 17 minutes prior to EMS arriving. No meds were administered in clinic.
Shaking; Swollen ankles; Cough; Joint pain; Chills; Low grade fever; Malaise; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of tremor in a 80-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.  Concurrent medical conditions included osteoporosis.  On 31-MAR-2023, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced tremor (Verbatim: Shaking), ankle swelling (Verbatim: Swollen ankles), cough (Verbatim: Cough), joint pain (Verbatim: Joint pain), chills (Verbatim: Chills), low grade fever (Verbatim: Low grade fever) and malaise (Verbatim: Malaise). The patient was treated with paracetamol (Tylenol). The outcome of the tremor and chills were resolved and the outcome of the ankle swelling, cough, joint pain, low grade fever and malaise were not resolved.  It was unknown if the reporter considered the tremor, ankle swelling, cough, joint pain, chills, low grade fever and malaise to be related to Shingrix.  It was unknown if the company considered the tremor, ankle swelling, cough, joint pain, chills, low grade fever and malaise to be related to Shingrix.  Additional Information: GSK Receipt Date: 10-APR-2023 The case was self-reported by the patient who was also a retired pharmacist. She stated that, she had received her first dose of Shingrix and she had experienced chills, shaking, low grade fever, malaise, swollen ankles, cough, and joint pain.  She was currently taking Tylenol for her fever. Chills and shaking had resolved, but all other symptoms were still present. The reporter did not consent to follow up.
One day after the vaccine, I experienced marked increase in pain and stiffness in my shoulders, hips, and hands. It progressed until December to the point where I couldn't get out of bed and had trouble walking. I fell once and couldn't get back up without the assistance of other people. I couldn't use my hands to open a water bottle. I took Advil in progressive doses up to 1600mg doses per day with modest improvement. I could walk and close my hand into a partial fist. I saw the doctor on 01/23/2023. The preliminary diagnosis was Polymyalgia Rheumatica. They prescribed Prednisone 20mg with a marked improvement in symptoms. I am about 80% better.
Student was alert and fine with MCV4 and Tdap given in left arm.   HPV was given in right arm student stated that one hurt, almost immediately the student eyes rolled back, her right arm came up and over her head quickly and she loss consciousness.  She was laid flat on exam table, LOC was very brief lasting a minute or two.  She regained consciousness but remained very pale, dizzy and weak.  Cool compresses were applied to forehead.  Student was slow moved from supine to sitting position over about 15 minutes.  She regained her cold, HR and BP were stable.  She was escorted out of clinic with father.
This consumer report (initial receipt: 15-Nov-2012) concerns a 50-year-old female patient, who had a medical history of 'deliac disease' (celiac disease). On 12-Nov-2012 the patient received AFLURIA (batch number was not provided) injection. On 12-Nov-2012, hours later, the patient's face and tongue swelled. Her heart rate increased. She suffered a headache, had a high fever and continuously kept throwing up. The patient did not seek medical attention. No lab diagnostic study was performed.
Arm pain, fever, chills, muscle aches, feeling of flu. Right eye pain and feeling of something in eye several day after injection.  White bump appeared inside of right eye next to cornea with redness. Small bumps appeared on eyelid. Apprx. 3 weeks after vaccination the tear duct closest to nose was swollen slightly and feels like something in eye. The feeling of something in eye also appeared in left eye after approx. 2 weeks. Still having these symptoms after 3 weeks.
the patient was administered improperly stored VARlVAX; This spontaneous report was received from a nurse and refers to a 4-year-old male patient. The patient's concurrent conditions, medical history and concomitant therapies were not reported.  On 07-AUG-2020, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot# T002848, expiry date 23-JAN-2022 (exact dose, route and site of administration were not reported) for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent.  The vaccine underwent the following temperature excursions: -14 to -10 degree Celsius (C) (-12.1C) for 3 hours (multiple excursions) and -9 to 8 C (-7.5C) for 8 hours and 30 minutes (multiple excursions). The call was because of digital data logger.
This spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical history provided. On unknown dates, the patient were vaccinated with improperly stored doses of ROTATEQ lot #M004542 with an expiration date 18-OCT-2017 and lot# M005732 with an expiration date 19-OCT-2017, orally (dose was not reported). Administrated doses of ROTATEQ experienced temperature excursion of 35 degrees Fahrenheit for 9 days. There was no previous temperature excursion. Digital data logger was not involved. No adverse effect was reported. No product quality complaint was involved. This is one of two reports received from the same reporter. Additional information has been requested.
rash is sensitive to touch; Rash itches; Hot rash at the injection site; Area of the rash itches; Hot rash at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCOMFORT (rash is sensitive to touch), RASH PRURITIC (Rash itches), VACCINATION SITE WARMTH (Hot rash at the injection site), VACCINATION SITE PRURITUS (Area of the rash itches) and VACCINATION SITE RASH (Hot rash at the injection site) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jul-2021, the patient experienced VACCINATION SITE DISCOMFORT (rash is sensitive to touch), RASH PRURITIC (Rash itches), VACCINATION SITE WARMTH (Hot rash at the injection site), VACCINATION SITE PRURITUS (Area of the rash itches) and VACCINATION SITE RASH (Hot rash at the injection site). At the time of the report, VACCINATION SITE DISCOMFORT (rash is sensitive to touch), RASH PRURITIC (Rash itches), VACCINATION SITE WARMTH (Hot rash at the injection site), VACCINATION SITE PRURITUS (Area of the rash itches) and VACCINATION SITE RASH (Hot rash at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications reported. No treatment information was provided.
Moderna Covid vaccine given 4/5/2021 and 5/3/2021.  Tested positive for Covid 7/25/2021
Developed generalized hives. Seen at Urgent care.  Given Prednisone.  Hives came back during taper. Continues to wax and wane on zyrtec.
Two days post vax, the pt developed a non-vesicular, red, raised, itchy rash on her inner thighs and arms. The pt denied any other symptoms and self-treated herself by using a cortisone cream and Benadryl. Follow up states one week post-onset, the patient recovered.
Neck pain on 2nd day, severe shoulder pain that has persisted for 7 days.
redness at the injection site; swollen at the injection site; lot of pain at the injection site; diarrhea; headache; fever 39 °C; chills; fatigue; muscular pain; joint pain; felt very bad; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (felt very bad), DIARRHOEA (diarrhea), HEADACHE (headache), PYREXIA (fever 39 °C) and CHILLS (chills) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 11-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, the patient experienced FEELING ABNORMAL (felt very bad), HEADACHE (headache), PYREXIA (fever 39 °C), CHILLS (chills), FATIGUE (fatigue), MYALGIA (muscular pain) and ARTHRALGIA (joint pain). On 10-Apr-2021, the patient experienced DIARRHOEA (diarrhea). On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (redness at the injection site), VACCINATION SITE SWELLING (swollen at the injection site) and VACCINATION SITE PAIN (lot of pain at the injection site). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, FEELING ABNORMAL (felt very bad), DIARRHOEA (diarrhea), HEADACHE (headache), PYREXIA (fever 39 °C), CHILLS (chills), FATIGUE (fatigue), MYALGIA (muscular pain), ARTHRALGIA (joint pain), VACCINATION SITE ERYTHEMA (redness at the injection site), VACCINATION SITE SWELLING (swollen at the injection site) and VACCINATION SITE PAIN (lot of pain at the injection site) outcome was unknown.            No concomitant medication was provided.
Warm redden area and swollen upper arm down to elbow with swollen lymph node at the inner part of the elbow.  Diagnosed by physician as a cellulitis, antibiotic infection and instructed to take benadryl , 25 mg, with as needed, apply ice pack to affected area.
Moderna 2/24/21, 3/25/21. Positive on 8/1/22
Mom reports pt had tingling/twitching of rt hand/arm 30 mins p/leaving ER; soon resulted in loss of consciousness & sz; tx @ ER transferred to another hosp for peds neuro; had 2nd sz 3 days later;
Soreness right away.  Tender when pressure place on it or laying on side.  Range of motion reaching upward or trying to reach behind (such as clasping a bra).  Has not improved over time.  Patient has seen her doctor (MD) about the continuing discomfort.  MD suggested exercise/PT and to report adverse reaction.
Noticed achy lt shoulder about 2 weeks after first TWINRIX shot. Persisting up to this date. Not sure when pain started but associates with shot. No pain med taken. Does not seem to change intensity, moderate discomfort. Does not change with movement.