chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Shingles; rash eruption; This is a spontaneous report from a contactable physician, the patient. A 49-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3248) via an unspecified route of administration in the right arm on 29Jan2021 at 08:00 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. Medical history included osteoarthritis, vitamin d deficiency, migraine headache and irritable bowel syndrome (IBS). The patient had no known drug allergy. Concomitant medications included famotidine (MANUFACTURER UNKNOWN), macrogol 3350 (MIRALAX), meloxicam (MANUFACTURER UNKNOWN), nebivolol hydrochloride (BYSTOLIC) and MVI; all taken for unknown indications from an unknown date and unknown if onging. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EH9899) via an unspecified route of administration in the right arm on 07Jan2021 at 07:30 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 12Apr2021 at 13:00, the patient developed shingles with rash eruption. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the reported events and included treatment with acyclovir (MANUFACTURER UNKNOWN) and NSAIDs. The clinical outcome of the events shingles and rash eruption were unknown at the time of this report.  No follow-up attempts are needed. No further information is expected.
Extreme full-body hives resulting in 2 ER visits over the course of 1.5 weeks. Never had any prior allergies to anything. Fully healthy individual. Hives are almost gone, however not completely and it's been almost 2 weeks.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 70-year-old male patient received BNT162b2 (BNT162B2), on 14Jan2021 as dose 1, single (Lot number: EL1284), in left arm, on 04Feb2021 as dose 2, single (Lot number: EN9581), in left arm, on 23Sep2021 as dose 3 (booster), single (Lot number: 301358A), in left arm and on 16Jun2022 at 01:00 as dose 4 (booster), single (Lot number: FP7531) at the age of 70 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Penicillin" (unspecified if ongoing). Concomitant medication(s) included: AMLODIPINE; GABAPENTIN; OMEGA 3-6-9. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. Therapeutic measures were taken as a result of vaccination failure, covid-19.
Hard lump at injection site noted 1 week post-injection. Warm, red, slightly itchy/irritating. Traced with pen and checked again 24 hours later for changes in size or shape and redness has grown outside of the traced area
Raspy tickling throat, coughing fever, tiredness, and body aches. Approximately 20 days later fatigue and body numbness appear on side of hands. A few days later legs starting getting weaker walking became more difficult.
Numb neck, face and jaw on same side as vaccine. 3 hours later still numb. No Bells Palsey symptoms tho.
Medical Assistant gave the patient a 0.5ml dose of PENTACEL and a 0.5ml dose of IPV to pediatric patient when the provider ordered a Dtap and IPV. This was a medication error. No injuries or adverse reaction reported, the patient is fine. This is a Federally Qualified Health Center. Medical assistant realized the error when she was documenting what she gave. Medical Assistant will double check the medication she pulled with the provider's order and she will check what she draw up with the provider order to make sure she have the correct medications ordered. Medical assistant to review the age appropriate vaccine schedule. The nurse verified the medical assistant is aware of which vaccines are included in PENTACEL.
I have had extreme tiredness or sleepiness prompting me to take a 1.5 to 2 hour nap every afternoon which is something I did not do prior to vaccine; I have had extreme tiredness or sleepiness prompting me to take a 1.5 to 2 hour nap every afternoon which is something I did not do prior to vaccine.; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205) via an unspecified route of administration in the right arm on 29Mar2021 at 12:00 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. Medical history included multiple sclerosis. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any concomitant medication within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6200) via an unspecified route of administration in the left arm on 03Mar2021 at 12:00 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. The patient previously took tetracycline (MANUFACTURER UNKNOWN) and clindamycin (MANUFACTURER UNKNOWN) and experienced drug allergy. The patient did not receive any other vaccines within four weeks prior to the vaccination. After second dose of Pfizer COVID vaccine, the patient had extreme tiredness or sleepiness prompting her to take a 1.5 to 2 hour nap every afternoon which was something she did not do prior to vaccine. This began on 30Mar2021, the day after second vaccine and had continued to the day of report. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events had extreme tiredness or sleepiness prompting to take a 1.5 to 2 hour nap every afternoon which was something she did not do prior to vaccine was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Patient was 17 years old when they got J&J vaccine. It was administered by Student. Patient has not reported any adverse reactions
Seizures on 2 separate events 16 May and 22 May in otherwise healthy male. Self-limiting. Scheduled to see neurology
immediate injection site pain; muscle pain; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 3rd February 2020, the patient received the 2nd dose of Shingrix .5 ml. On 3rd February 2020, immediately after receiving Shingrix, the patient experienced injection site pain and muscle pain. On 4th February 2020, the outcome of the muscle pain was recovered/resolved. On an unknown date, the outcome of the injection site pain was not recovered/not resolved.   It was unknown if the reporter considered the injection site pain and muscle pain to be related to Shingrix.  Additional details were provided as follows: The patient received dose 2 and had immediate injection site pain that was still ongoing at the time of reporting.  The patient developed muscle pain with in a few hours of the second dose and that was resolved. The reporter did not consent to follow-up. This is 1 of 3 cases reported by same reporter.
had a sore arm; having soreness and pain under my armpit in the arm where I received the vaccine.; This is a spontaneous report received from a contactable reporter (Consumer) from medical information team. The reporter is the patient.  A 56-year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "had a sore arm"; AXILLARY PAIN (non-serious), outcome "unknown", described as "having soreness and pain under my armpit in the arm where I received the vaccine.".  Additional Information: After the first dose, the patient had a sore arm at first. On the third day, she started having soreness and pain under her armpit in the arm where she received the vaccine. The patient was asking if this was a side effect and if she should receive the second dose.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
4/1 son arrived and she got sick - stomach and general feeling of unwell; couldn't eat.  Increase in shortness of breath (she had this with COPD); 4/2 and 4/3 continued to feel sick as described above. 4/5 son drove her to the hospital; she was dx COVID + in the ED. (note that on 3/27 she shopped with her daughter in law and ate in restaurant)
48 hours after the injection I began to notice a sore throat before bedtime on Dec 30, but slept well. The next morning, Dec 31, I had acute allergic symptoms that never start so suddenly.  I was having constant Post-nasal Drip, nasal congestion and beginning of cough due to PND.  That night I had a severe sore throat similar to my typical allergic pattern.  I coughed all night and awoke on the morning of Jan 1st with clear severe onset allergies and could not talk without coughing.  That persisted for 4 days, then my allergist prescribed inhaled steroids BID which reduced the nighttime cough, but I persisted with symptoms for 10 days when they slowly resolved and my sense of well-being returned.  I missed 7 days of work, which is atypical for my allergies when I catch them early.  This was an acute flare of typical allergic symptoms that seems to have been triggered by the timing of the immune change from the vaccine at day #2-3 after the vaccine #1 was given.  I  am worried about getting vaccine #2 in 2 weeks and don't want to go through another flare up of dialing allergies again.
Intense pain in L deltoid from the medial/lateral side down to hand beginning at time of injection.  Throughout rest of evening continued to have intense pain and "tired muscle" that became less severe and continued to have pain in fingertips that rotated into "all of my extremities and in fingertips and toes in the last year that comes and goes."  Sept 2023 began having tingling in extremities with "near syncope."  October 2023 began experiencing numbness and tingling in legs and arms bilaterally, this is "the first time I went to see a doctor.  Continue to have dizziness and easily fatigue with rapid heartbeat and pain that "feels like peripheral neuropathy."  I've had 2 ER admission and missed alot of work.
Stomach pain; Back pain; Rash on stomach and back; This case was reported by a consumer and described the occurrence of stomach pain in a 60-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30th November 2022, the patient received the 1st dose of Shingrix. On 7th December 2022, 7 days after receiving Shingrix, the patient experienced stomach pain and back pain. In December 2022, the patient experienced rash. On an unknown date, the outcome of the stomach pain, back pain and rash were not recovered/not resolved.   It was unknown if the reporter considered the stomach pain, back pain and rash to be related to Shingrix.   Additional Information: GSK receipt date: 15-DEC-2022 Reporter's comment: The patient was administered first dose of Shingrix on 30th November 2022 and one week after experienced stomach and back pain also after Eleven days rash on stomach and back from 7th December2022.  The Reporter mentioned seriousness criteria for one week after, stomach and back pain and Eleven days after rash on stomach and back as Intervention required.
Staff member received vaccine .At the 15 minute mark, she reported a headache with pressure behind right eye,slight dizziness. It was described as a rapid onset migraine  headache with photosensitivity .She was escorted to empty room with staff and laid down. she was examined per Dr.At the 20 minute mark, she developed a light red rash and began itching. The itching began at the face, radiated to arms and legs and then trunk. No c/o  SOB, chest pain  or increased heart rate. She reported that it felt like someone poking a finger to her left chest wall for 5 minutes-gently.B/P elevated and monitored by staff for  3.5 hrs and was able to go home with staff/family.
In 10 minutes left arm went numb...persisted all day. Next day all four extremities, feet and hands numbness and tingling
This spontaneous report was received from a physician refers to a female patient of unknown age. On 06-APR-2013 the patient was vaccinated with 0.65 milliliter (ml) ZOSTAVX (lot# and expiration date not provided), subcutaneous at an unspecified pharmacy. The patient visited the physician's office on 12-APR-2013 (also reported as today) with a rash on her neck. The rash was red but did not look like a "herpes rash" according to the physician. Physician said that rash appeared to be non-specific eczema. Physician stated that the patient would be calling with more information. The outcome of non-specific eczema is unknown. Causality was not reported. Additional information has been requested.
Damage to rotor cuff; Frozen shoulder; arm she felt soreness which; This spontaneous case was reported by a physician and describes the occurrence of periarthritis, pain in extremity and rotator cuff syndrome in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.  The patient's past medical history included No adverse event.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced PAIN IN EXTREMITY (arm she felt soreness which). On 30-Jan-2021, the patient experienced PERIARTHRITIS (Frozen shoulder). On 05-Feb-2021, the patient experienced ROTATOR CUFF SYNDROME (Damage to rotor cuff). On 30-Jan-2021, PAIN IN EXTREMITY (arm she felt soreness which) outcome was unknown. On 02-Feb-2021, PERIARTHRITIS (Frozen shoulder) had resolved. At the time of the report, ROTATOR CUFF SYNDROME (Damage to rotor cuff) 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 were provided No treatment information provided
Patient received 2 doses of Moderna Vaccine on 01/22/2021 and 02/24/2021. On 09/28/2021, she came for a Booster vaccine and was given Pfizer.
Information has been received from a female consumer concerning her 22 year old daughter with no medical history and no drug allergies, who was vaccinated with all three doses of GARDASIL. The therapy started over one year ago. The daughter started to gain weight shortly after her 3rd dose of GARDASIL in approximately November 2008 late fall. Concomitant medication included "the mini pill". There were no labs and diagnostic tests performed. The patient hadn't sought medical attention. At the time of the report, the patient's status was unknown. No further information is available.
Developed feverish feeling, stiff neck, and vesicular eruptions on 2/26/03. More eruptions (total 5-6) on 2/27/03. All vesicles healed 3/5/03.
my 6 month old, whom I am breastfeeding, became sick with a moderate fever for 3 days and then a rash about a week about 10 days later; my 6 month old, whom I am breastfeeding, became sick with a moderate fever for 3 days and then a rash about a week about 10 days later; my 6 month old, whom I am breastfeeding, became sick with a moderate fever for 3 days and then a rash about a week about 10 days later; my 6 month old, whom I am breastfeeding, became sick with a moderate fever for 3 days and then a rash about a week about 10 days later; This is a spontaneous report received from a contactable other healthcare professional. This reporter reported information for both mother and fetus/baby. This is the baby report. Only this case is serious. A 6-months-old patient of an unspecified gender received second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via other routed of administration on 22Mar2021 10:00 (Batch/Lot Number: ER8727) as single dose for covid-19 immunisation. Patient received the first dose on 01Mar2021 10:00 with lot number EN6202. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient's mother reported that separately, her 6 month old, whom she was breastfeeding, became sick with a moderate fever for 3 days and then a rash about a week about 10 days later. Outcome of events was unknown.   No follow-up attempts are needed. No further information is expected; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2021387880 same reporter/drug, different patient/event(mother case)
Just slept; My arm was swollen for a month; Lymph nodes were swollen; Felt Congested; Got rash all over my body; Got hives; Still having aches in back \ The pain has moved to lower back; Having pain in upper chest; Stomach hurts; Have body aches \ Have muscle aches \ Still having aches in arm; Had headaches; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (Just slept), PERIPHERAL SWELLING (My arm was swollen for a month), LYMPHADENOPATHY (Lymph nodes were swollen), MALAISE (Felt Congested) and RASH (Got rash all over my body) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Pollen allergy and Dust allergy.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SOMNOLENCE (Just slept), PERIPHERAL SWELLING (My arm was swollen for a month), LYMPHADENOPATHY (Lymph nodes were swollen), MALAISE (Felt Congested), RASH (Got rash all over my body), URTICARIA (Got hives), BACK PAIN (Still having aches in back \ The pain has moved to lower back), CHEST PAIN (Having pain in upper chest), ABDOMINAL PAIN UPPER (Stomach hurts), MYALGIA (Have body aches \ Have muscle aches \ Still having aches in arm) and HEADACHE (Had headaches). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date for Pain, at a dose of 1 dosage form. At the time of the report, SOMNOLENCE (Just slept), PERIPHERAL SWELLING (My arm was swollen for a month), LYMPHADENOPATHY (Lymph nodes were swollen), MALAISE (Felt Congested), RASH (Got rash all over my body), URTICARIA (Got hives), BACK PAIN (Still having aches in back \ The pain has moved to lower back), CHEST PAIN (Having pain in upper chest), ABDOMINAL PAIN UPPER (Stomach hurts), MYALGIA (Have body aches \ Have muscle aches \ Still having aches in arm) and HEADACHE (Had headaches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication were not reported   Most recent FOLLOW-UP information incorporated above includes: On 14-Jun-2021: Follow-up received on 14-jun-2021, Reporter information was updated
This spontaneous case was initially received on 29-Oct-2015. The case report was received from a Non Health Professional and concerns a female patient. Weight: not provided, Height: not provided. For concomitant medication and therapy dates refer to the appropriate report sections. The patient received AFLURIA on 19-Oct-2015 - 19-Oct-2015. Batch no: not provided, Route of administration: Intramuscular, Dose: 0.5 ml. No additional drugs suspected. On 19-Oct-2015, 1 day after starting treatment with AFLURIA the patient experienced shoulder pain/Shoulder was in pain, Heartburn, Fatigue/Fatigued, Injection site itching/Injection site itched very badly, Stomach upset. Action taken: discontinued. Dechallenge/Rechallenge: not applicable. For relevant test results see appropriate report section. Report's assessment: the reporter considered events non serious.
Extreme fever and extreme body aches and headache. Fever consistently at 103.2 or 4, can't stand on feet without hips feeling like they're going to buckle. Extreme chills to the point of shaking. Headache is worst headache of my life.
01/08/21- lymph node swelling under my left armpit painful, swelled to the size of a lime it lasted for about 2 weeks like that it eventually started to go down and it went away. There was not treatment. I went to see the advise of some doctors and they said it would probably go down on its own, just to keep an eye on it. I only had some tiredness after the vaccine, and that was it.
Pregnancy was healthy normal pregnancy.  Due date 8/31/21.  Birth weight 6lbs 6oz.  Cord was knotted and around babies neck.  Baby delivered safely.
6/10: Lethargy, cek pain, headache, hematuria.  6/14:  Chest pain and erythema at injection site.  6/14 To ED for chest pain and transferred to Medical Center for cardiology work up and infectious disease.