chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient states that while vacationing, 3 weeks and 1 day after receiving her Janssen vaccine, she woke up at 8:30am with numbness in her left foot. When attempting to stand she fell to floor. After checking her blood pressure and blood sugar she took 2 tylenol and sat down to rest. Around 10:30am she began to have numbness in her left hand and on the left side of her face. She was taken by ambulance at that time to Hospital. While there they ran a number of tests and scans diagnosing her with have a stroke caused by a small blood clot in right side of her brain. She was admitted to the hospital and was not discharged until 4/3/2021. Upon returning home, she has been seeing her PCP, APRN and a neurologist. She has since been released on 4/19/2021 to go back to work and has no residual side effects from stroke. She states she is now on blood pressure and cholesterol medication and is taking a daily baby Aspirin.
Initial report received on 10 November 2006 a health care professional. A 45-year-old female patient had inadvertently received a left deltoid, intramuscularly injection if Daptacel, (product not recommended for use in this age group). lot number C2630AA, on 18 August 2006. This product was administered instead of Adacel. The following day, the patient experienced muscle soreness. No testing or examination by a physician was required. The patient took nonsteroidal anti-inflammatory medications as needed. The patient recovered from the event within 96 hours. The reporter in this case in the same as the reporter in cases 2006-02409, 2006-03043, 2006-03044, 2006-03045, 2006-03047, 2006-03048, 2006-03049, 2006-03050, and 2006-03051.
The report was first received from a practice manager on 07-SEP-2018, and it was recognized as non-valid because report did not obtain any patient identify. Follow-up information has been received from the practice manager on 18-SEP-2018. This spontaneous report refers to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided. On 21-AUG-2018, the patient was vaccinated with an improperly stored dose of ROTATEQ (strength were unknown) (lot# N030174 and expiration date 13-JUN-2019) orally for prophylaxis (Incorrect product storage). The sterile diluent (MERCK) (lot# and expiration date were unknown) was properly stored. No adverse event was reported. The excursion temperature on 08-NOV-2017, 16-NOV-2017, 23-JAN-2018, 06-JUN-2018, 03-JUL-2018 and 14-AUG-2018 was 47 degree Celsius for maximize 15 hours. The excursion temperature on 07-DEC-2017 was 50 degree Celsius for maximize 8.75 hours. The call was not because of data logger. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1809USA003709: US-009507513-1810USA001951: US-009507513-1810USA001952: US-009507513-1810USA001953: US-009507513-1810USA001954: US-009507513-1810USA001955: US-009507513-1810USA001956: US-009507513-1810USA001957: US-009507513-1810USA001958.
This spontaneous report as received from a medical assistant refers to a 1 year old patient of unknown gender. The patient's drug allergies and pertinent medical history was not reported. On 08-JUL-2014 the patient was vaccinated with first dose of VAQTA, (dose, frequency and route of administration were not reported) (lot # J005010, expiry date: 23-OCT-2015) which was stored improperly. No adverse effects were noted. No product quality complaint was reported for VAQTA. This case is linked to 1407USA010956, 1407USA012902, 1407USA012903, 1407USA012904, , 1407USA012905, 1407USA012906, 1407USA012907, 1407USA012908, 1407USA012909, 1407USA012910, 1407USA012911, 1407USA012912, 1407USA012913, 1407USA012914, 1407USA012915, 1407USA012916, 1407USA012917, 1407USA012918, 1407USA012919, 1407USA012920, 1407USA012921, 1407USA012922, 1407USA012923, 1407USA012924, 1407USA012925, 1407USA012926, 1407USA012927, 1407USA012928, 1407USA012929, 1407USA012930, 1407USA012931, 1407USA012932, 1407USA012933, 1407USA012934, 1407USA012935, 1407USA012936, 1407USA012937, 1407USA012938, 1407USA012939, 1407USA012940, 1407USA012941, 1407USA012942, 1407USA012943, 1407USA012944, 1407USA012945, 1407USA012946, 1407USA012947, 1407USA012948, 1407USA012949, 1407USA012950, 1407USA012951, 1407USA012952, 1407USA012953, 1407USA012954, 1407USA012955, 1407USA012956, 1407USA012957, 1407USA012958, 1407USA012959, 1407USA012960, 1407USA012961, 1407USA012962, 1407USA012963, 1407USA012964, 1407USA012965, 1407USA012966, 1407USA012967, 1407USA012968, 1407USA012969, 1407USA012970, 1407USA012971, 1407USA012972, 1407USA012973, 1407USA012974, 1407USA012975, 1407USA012976, 1407USA012977, 1407USA012978, 1407USA012979, 1407USA012981, 1407USA012982, 1407USA012983, 1407USA012984, 1407USA012985, 1407USA012987, 1407USA012988, 1407USA012989, 1407USA012990, 1407USA012991, 1407USA012992, 1407USA012993, 1407USA012994, 1407USA012995, 1407USA012996, 1407USA012997, 1407USA012998, 1407USA012999, 1407USA013000, 1407USA013013 and 1407USA01304 (same reporter link).
Severe headache; confusion; unable to get clear thoughts communicated; This is a spontaneous report from a contactable other healthcare professional. An 83-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number and expiration date not reported) intramuscular on the left arm on 15Jan2021 10:45 at a single dose for COVID-19 immunization. The patient had no medical history. The patient's concomitant medications were not reported. On 16Jan2021 08:00 AM, the patient experienced severe headache, confusion, unable to get clear thoughts communicated. No treatment was received. Patient was not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There were no other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient has not been tested for COVID-19. No known allergies. Outcome of the events was not recovered.   Information on Lot/Batch has been requested.
Ten days after my injection, I now have a large circle and rash at the injection site. The circle is warm to the touch. My doctor recommended Arnica cream to sooth the infection.
She got her vaccine, and an hour afterwards started with dizziness and nausea, which progressively got worse and still has.  On 3/27/21 woke up with severe chills and a high fever of 102.3, which lasted all day.  Yesterday had temp of 99.4 and 98.8.  Has had decreased urination, little urinary output, dizziness, has taken Zofran, Antivert and the headache is unrelenting and feels like somebody took a bat to her head, and the migraine is the worst one she has had and feels so weak that she cannot function at all.  She has taken Emitrex once, and Toradol IM.  She almost fell on Saturday at home due to the dizziness and none of her medications have helped any of the symptoms.    She has been drinking water, just sips at a time, tried Gatorade yesterday but it made her sick to her stomach.   She is having soaking sweats, and possibly fevers as well.
I have been in menopause for 7 years,  taking Estradiol-Norethindrone.5-.1 mg daily for the last 16 months. I have not had a menstrual cycle for more than 7 years. I began menstrual bleeding around 36 hours after receiving Jansen COVID 19 vaccine. Experienced continuous daily bleeding for 6 days. Did not experience ant other symptoms.
pain mid arm, 5/10 mid upper arm at the end of deltoid muscle, no bruising and swelling, no increase pain with pressure to area; some improvement with warm compress; no change in ROM, no neuropathy
Inappropriate age at vaccine administration; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 15-year-old male patient who received DTPa-HBV-IPV (Pediarix) (batch number 9X3T5, expiry date 5th March 2023) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 16th June 2022, the patient received Pediarix and Pediarix Pre-Filled Syringe Device. On 16th June 2022, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration 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: 13-JUL-2022 Reporter's Comment:  The reporter consented to follow-up. Additional Supportive Information: The 15 years old patient received a dose of Pediarix, which led to Inappropriate age at vaccine administration.
Patient was inadvertently given another dose of Comirnaty when he requested a flu shot. Previous Covid vaccination was 10/17/23.
sore left arm with possibility of nausea and vomiting Patient presents to the office today for: injury, right foot. He reports receiving a puncture injury to his right foot x2 days ago [Saturday] by stepping down on a nail while replacing carpet. He doesn't think the nail was rusty and notes "it went in and out quickly" The area is swollen and a bit bruised. Was wearing both shoes and socks. Denies fever, chills. The injury has remained stable, feels the same no better or worse. He felt well enough to go motorcycle riding over at the coast the next day.
Immediately after the vaccine had a red spot on her wrist that was itching.  Later that night her wrist started itching more and had 3-4 areas that blistered up and itching..  The right eye upper eyelid and underneath was itching really bad.  Monday, 2/8/21, she called her NP and told her that she was breaking out all over her body and she needed a steroid shot.  She went to a fast pace clinic and they would not give her a shot, told her to take Benadryl, antihistamines and Pepcid AC.  She continued to break out and she is broken out from her head to almost her feet.  She went and saw her doctor who told her to take a stronger dose of Benadryl, gave her a Medrol dose pack, but still having itching, and the break out.  They are red and itchy.  Her doctor also gave her the cortisone cream to put on it, but she is covered and cannot use the cream all over her body.    The rash looks like the COVID rash that she has seen online.   Does have a return apt with her doctor in a week.
Sore left arm; Patient felt tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore left arm) and FATIGUE (Patient felt tired) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination.     Concurrent medical conditions included Lactose intolerant, Caffeine allergy, Food allergy (Allergic to fatty products), Meat allergy (Allergic to pork products), Allergy to antibiotic, Drug allergy (Allergic to Novacaine), Drug allergy (antidepressant drugs (not all of them), depression medications), Anxiety, Type 2 diabetes mellitus (Recent change in status such as improvement or worsening: no) since 2016 and Blood pressure high (Recent change in status such as improvement or worsening: no) since 2019. Concomitant products included CORTISONE for Arthritis, AMLODIPINE BESYLATE for Blood pressure high, CLONAZEPAM, LOSARTAN, PARACETAMOL (TYLENOL [PARACETAMOL]), CALCIUM, NICOTINAMIDE (VITAMIN B3), MULTIVITAMIN [VITAMINS NOS] and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.    On 04-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore left arm) and FATIGUE (Patient felt tired). On 04-Mar-2021, PAIN IN EXTREMITY (Sore left arm) and FATIGUE (Patient felt tired) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Treatment medication details was provided Cortisone shots on her knees for arthritis every 3 months Patient was reported that the patient never had COVID positive test or diagnosis. No other vaccines were given within 1 month prior to Moderna COVID-19 vaccine. The Adverse events did not cause patient to seek medical care and the patient had not experienced a similar event in the past. The adverse event outcome was reported as recovered and the symptoms had recovered. The patient's height reported as 5 feet 3 inch.   This case was linked to MOD-2022-484121, MOD-2022-484156 (Patient Link).
2 weeks after vaccination later-pain in foot, 7 month later-tingling, red inflammed feet
Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Numbness (specify: facial area, extremities)-Medium
Started having fever at 7:00 p.m. (100 degrees). At 3:00 a.m. was 101 degress.  At 8:30 a.m. 101 degress.  Saw doctor at 9:00 a.m.  Checked for strep throat because he said his throat was hurting "bad".  Swab for strep was negative.  Lethargic.  Will eat but appetite is not normal.  Fever all day.  Treated with Tylenol.  Still not feeling well.
Timeline: Vaccine 1: 100.1 temp x 1 day. Resolved. No residual symptoms  Vaccine 2: chest tightness, mild shortness of breath; upper back pain/tightness; tachycardia.  Resolved in about 4 days. Contact with COVID19 positive family member 07/10/2021.  Cared for ill family member 7/10/21 -7/18/21. Experiencing symptoms of chest tightness and upper back pain + O2 sats 92-93% on room air. And brain fog.  Rapid and PCR test negative 7/12/21. Headache and nasal congestion 7/16/21. Rapid test negative 7/19/21 but developed fever of 101.6 1 hour after test.  PCR returned 7/14/21 positive. Experienced fever, sinus pressure/pain, loss of smell, and mild diarrhea x 4 days. O2 sats 96-97% on room air.   7/26/2021 to present: intermittent chest tightness, upper back tightness/pain. Intermittent dyspnea on exertion and when wearing N95+shield.; occasional short episodes tachycardia with activity .
On Thursday started having some lower back pain; His legs and knees are starting to hurt/legs are aching and knees; his legs and knees are starting to hurt/legs are aching and knees; Immediately had chills/ Chills; Laid down and was kind of cold; This is a spontaneous report from a contactable consumer or other non-HCP (patient). A 41-years-old male patient received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EW0162, Expiry date: UNKNOWN) via an unspecified route of administration in left arm (left shoulder) on 13Apr2021 11:45 as dose 1, single (at the age of 41-years-old) for COVID-19 immunization. The patient medical history and concomitant medications were none. No family medical history relevant to adverse events. No investigation assessment. The vaccine was not administered at military facility. The patient experienced immediately had chills on 13Apr2021, on Thursday started having some lower back pain, his legs and knees are starting to hurt/legs are aching and knees on 15Apr2021, laid down and was kind of cold on an unspecified date in 2021. Reporter wanted to know is this normal and how long will it last. Reports chills started same date he received the shot recovered completely the same day. Caller laid down after receiving the Pfizer Covid Vaccine dose one, laid down when caller got home. Laid down and was kind of cold, that stood out to the caller. After that he hasn't had the chills again. Clarifies the lower back pains, legs aching and knees began on 15Apr2021, Lower back pains reports the lower back pains have gotten better. Legs are aching and knees: Reports this is kind of new, but it was going on a little bit. Lower back pains lower back pain is improving. Legs are aching and knees the legs are pretty much the same. Patient was not taken any prior vaccinations within 4 weeks and no adverse events following prior vaccinations. Patient was not taken any additional vaccines administered on same date of the pfizer suspect. There were no relevant tests. So far, the patient was not visited to Emergency room or Physician office. The outcome of chills recovered on 13Apr2021, lower back pain was recovering/Resolving (improving), legs and knees are starting to hurt/legs are aching, and knees was not recovered (pretty much the same) and kind of cold was unknown.  No follow-up attempts are needed. No further information is expected.
This is a spontaneous report from a non-contactable consumer. A male patient of an unspecified age and ethnicity received a single dose of PREVNAR 13 on an unspecified date. Medical history and concomitant medications were not reported. The patient died from Guillain-Barre syndrome on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected.
Pt recv vax on 2/17/99; 30 min post vax pt exp right face droop
Tightness in the Chest; Increased Reflux; Flushing of the face; Itchy all over; Difficulty Swallowing; Pain in chest; This is a spontaneous report from a contactable consumer or other non-health care professional (Patient).  A 75-years-old female patient received bnt162b2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection; (Batch/Lot Number: Unknown) via an unspecified route of administration, administered in Arm Left (reported as Left Upper Arm) on 17Mar2021 (at the age of 75-years-old) as dose 1, single for covid-19 immunization. Medical history included ongoing stomach Issues and she has had stomach issues for about 4 years and was being treated for them and patient took Flu Vaccine on an unknown date in 2020. The patient's concomitant medications were not reported. Patient took Flu Vaccine and had similar symptoms as she experienced after the Covid Vaccine with the Flu Vaccine and said they were milder though, reported as AE prior vaccination. Family history reported as None. No prior vaccinations taken within 4 weeks of vaccination. No additional vaccines administered on same date of the Pfizer Suspect. It was reported that, patient wanted to report some severe side effects that she had with her first dose of the vaccine. she was fine immediately after the vaccine but once it got into her system these symptoms began and all of her symptoms began about 4 days after her vaccine. On 21Mar2021, the patient experienced tightness in the chest, increased reflux, flushing of the face, itchy all over, difficulty swallowing, pain in chest. Events were all improving slowly and the most concerning one to her was the difficulty swallowing. On an unspecified date, it was reported that she was not going to get the second dose of the vaccine which was scheduled for safety reasons. No doctor or emergency room visits related to patient reported events and she stated that she called her doctor and discussed her side effects. No Investigation Assessment was provided. Outcome of the events was recovering.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained. No further information is expected.
10/13/22 I had previous issues with my knee. But, my knee started getting to the point I could not put my weight on it. I could not walk and had to start using a cane. I was in a lot of pain. I saw my doctor and he scheduled surgery for 12/19/22 which I have had.
Swelling of shot area. Tingling from area down to fingers, feels like pins and needles, can't raise arm (left), hurts around to my shoulder blade.
Swelling, hardness, redness in ~3" circle around injection sight  Pain and stiffness in injection arm
Suspected Bullous Pemphigoid; bullous disorder; Seborrheic Dermatitis unspecified; Folliculitis; Acne; pruritic rash; rash on abdomen and arms; Back pain; Shingles; pruritis on his face and scalp; blistering rash; This case was reported by a lawyer and described the occurrence of suspected bullous pemphigoid in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced suspected bullous pemphigoid (serious criteria GSK medically significant). The action taken with Shingrix was unknown. On an unknown date, the outcome of the suspected bullous pemphigoid was unknown.   It was unknown if the reporter considered the suspected bullous pemphigoid to be related to Shingrix.  The initial information was received on 03 April 2020 via medical records(The case was medically confirmed). As per medical records, the patient had GSK suspect Herpes Zoster (shingrix) vaccine 0.5mL IM given (1st of 2). Left Deltoid on 24 April 2018. On 24 April 2018 the patient had blistering rash. As per progress date 05 September 2018 the patient had biopsy of a blister that developed overnight, seborrheic dermatitis unspecified, acne, pruritic rash, bullous disorder, folliculitis, suspected  bullous pemphigoid. The patient had rash on his abdomen and scattered on his arms, back pain and shingles and pruritis on his face and scalp.
lymph nodes got really big on the same side as where she received the vaccine/ They almost felt like gel marbles.; Felt like she was arm wrestling and unable to reach to the top of her head/arm felt extremely heavy; soreness and redness around injection site; soreness and redness around injection site; fatigued; arm felt extremely heavy; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (arm felt extremely heavy), LYMPHADENOPATHY (lymph nodes got really big on the same side as where she received the vaccine/ They almost felt like gel marbles.), VACCINATION SITE SWELLING (Felt like she was arm wrestling and unable to reach to the top of her head/arm felt extremely heavy), VACCINATION SITE PAIN (soreness and redness around injection site) and VACCINATION SITE ERYTHEMA (soreness and redness around injection site) in a 43-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.     Concomitant products included VITAMINS NOS and FAMOTIDINE (PEPCID [FAMOTIDINE]) for an unknown indication.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced LIMB DISCOMFORT (arm felt extremely heavy), VACCINATION SITE SWELLING (Felt like she was arm wrestling and unable to reach to the top of her head/arm felt extremely heavy), VACCINATION SITE PAIN (soreness and redness around injection site), VACCINATION SITE ERYTHEMA (soreness and redness around injection site) and FATIGUE (fatigued). On 09-Mar-2021, the patient experienced LYMPHADENOPATHY (lymph nodes got really big on the same side as where she received the vaccine/ They almost felt like gel marbles.). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 05-Mar-2021, VACCINATION SITE SWELLING (Felt like she was arm wrestling and unable to reach to the top of her head/arm felt extremely heavy) had resolved. On 06-Mar-2021, LIMB DISCOMFORT (arm felt extremely heavy) had resolved. At the time of the report, LYMPHADENOPATHY (lymph nodes got really big on the same side as where she received the vaccine/ They almost felt like gel marbles.) had not resolved and VACCINATION SITE PAIN (soreness and redness around injection site), VACCINATION SITE ERYTHEMA (soreness and redness around injection site) and FATIGUE (fatigued) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.