chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Bad pain in the right side of his back; difficult to walk; shooting pain when walking on left side; leg muscles were bothering him/pain goes down his leg to his calf; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Bad pain in the right side of his back), GAIT DISTURBANCE (difficult to walk), PAIN (shooting pain when walking on left side) and MYALGIA (leg muscles were bothering him/pain goes down his leg to his calf) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Bypass surgery. Concurrent medical conditions included Diabetes.    On 04-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In December 2021, the patient experienced BACK PAIN (Bad pain in the right side of his back), GAIT DISTURBANCE (difficult to walk), PAIN (shooting pain when walking on left side) and MYALGIA (leg muscles were bothering him/pain goes down his leg to his calf). At the time of the report, BACK PAIN (Bad pain in the right side of his back), GAIT DISTURBANCE (difficult to walk), PAIN (shooting pain when walking on left side) and MYALGIA (leg muscles were bothering him/pain goes down his leg to his calf) outcome was unknown.            No concomitant medications reported. No treatment reported.
Dizziness, seeing black dots and nauseous 6 minutes after receiving first dose of Covid vaccine.  My heart rate was 158 and BP was 139/93.  I was taken by ambulance to ER and they monitored my heart rate and BP for the next three hours. Then sent home.
65+ dose administered to 38 year old employee  Heart palpitations following that night for a few hours
Chest tightness; SOB; This is a spontaneous report from a contactable pharmacist. A 33-year-old female patient received the second single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EL0142) intramuscular, in left arm, on 02Feb2021 at 15:00, for COVID-19 immunisation. The patient received the first dose of BNT162B2 on 14Jan2021 at 19:30, from lot EL3302, intramuscular, in left arm. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since vaccination, the patient had not been tested for COVID-19. Medical history included lymphoid leukemia, allergies to asparaginase and pegaspargase (anaphylaxis), vancomycin, fluticasone propionate (FLONASE). Concomitant medications were not reported. The patient waited 30 minutes in clinic. As she was exiting, she felt chest tightness and SOB starting from 02Feb2021 at 15:15. Rapid response called. She was evaluated by RR and dc'd back to clinic. Chest tightness improved. Refused ED. No treatment was administered. The events were reported as non-serious and resolved on an unspecified date in Feb2021.
This spontaneous report was received from a 67 year old female consumer without drug reactions/allergies or pertinent medical history regarding herself. In February 2010, the patient was vaccinated with ZOSTAVAX, 1 time vaccine, subcutaneous for prevent shingles (lot number and expiration date not reported). There was none concomitant medication. On 18-SEP-2013, the patient has shingles, after receiving the vaccine. No lab diagnostic were performed. In September 2013, the patient sought unspecified medical attention and was treated with antivirals and pain pills. The outcome of shingles was unknown. Additional information has been requested.
Waking up multiple times throughout the night; This is a spontaneous report from a contactable consumer reported for a patient (mother in law). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: Not Provided), via an unspecified route of administration on an unspecified date as UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Reportedly, his mother-in-law did get the Pfizer COVID vaccine in a different town, and she has had the same issue where she is waking up multiple times throughout the night but she is taking it like it is part of her new normal and she is not complaining about it. Probed if caller would like to complete a safety report for his mother in law and he declined. He said that he would let her know about this and he also did let her know about the VAERS system and he is just leaving it up to her if she wants to report on her own behalf. On an unspecified date, the patient experienced waking up multiple times throughout the night. Outcome of the event was unknown.  Additional Context: Caller is a 43 y/o male. Reports he received his first Pfizer Covid vaccine dose on 27Mar2021. On 31Mar2021, he woke up with a shock in his chest and has woken up every night since then with a shock. He states he falls asleep and then wakes up an hour later every night. He also reports this "shock" sensation in his intestinal area. He reports his limbs have been twitching, he has a headache that feels like vibrating inside of his head. He also reports a vibrating sensation in his chest and abdomen. He did not receive the second dose of the vaccine. He reports a loss of sensation in his penis. He wants to know if these side effects have been reported before and what to do about them. Will e-transmit as duplicate AE. He reports his mother-in-law has also experienced wakefulness after receiving the Pfizer Covid vaccine. Response: Referred to HCP and spoke from attached document FACT SHEET FOR HCPs ADMINISTERING VACCINE; FULL EUA PI (v1.0) (LAB-1450-8.0 Revised: 10 May 2021) section 6.1 Clinical Trials Experience and from VR Consumer Inquiry Management (Off-Label or No Info) (v15.0).  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Information has been received from a physician concerning a female (age not reported) with a sulfonamide allergy and no other pertinent medical history reported. On 22-DEC-2006, the patient was vaccinated with 0.5ml of Gardasil ( Lot #655165/1425F). There were no concomitant medications reported. On 29-DEC-2006, one week after the injection, the patient developed a rash on her arms, legs and abdomen. The patient sought unspecified medical attention. It was reported that the rash had since cleared up but the date was unknown. At the time of this report, the patient had recovered from the event. Additional information has been requested. 5/14/10 Follow up: The patient took Benadryl for 24 hours and itching resolved. No diagnostic laboratory tests were performed. On 12-JAN-2007, the patient had recovered completely. Additional information is not expected.
This spontaneous report as received from a physician refers to a 6 month old patient. On 24-MAY-2014 the 6 month old patient was vaccinated with a first dose of GARDASIL (dose, route and lot # not reported). No adverse symptoms reported. Additional information has been requested.
Temp- 102, chest pain, body aches, headaches, vomiting. Saw primary in the AM and went to the ER from there.
Next morning post vax, the pt complained of headache for 2 days and low grade temperature 99-100. No rash appeared.
flu-like symptoms; chest pains; cough; fever; pleurisy; This is a spontaneous report from a contactable consumer (Patient). A 49-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: ER8736), dose 1 via an unspecified route of administration, administered in Arm Left on 04May2021 at 12:15 (Age at vaccination: 49 years) as dose 1, single for covid-19 immunisation. Medical history included insomnia, anxiety, depression, ankylosing spondylitis. Concomitant medications included paracetamol (TYLENOL); eszopiclone (LUNESTA); Citalopram; ascorbic acid, ergocalciferol, nicotinamide, retinol, riboflavin, thiamine hydrochloride (VITAMINS [ASCORBIC ACID; ERGOCALCIFER-OL;NICOTINAMIDE;RETINOL; RIBOFLAVIN;THIAMINE HYDROCHLORIDE]) . Patient did not have allergies. Patient did not receive other vaccines in 4 weeks. Patient did not had COVID prior vaccinations. Patient tested COVID post vaccination. The patient experienced flu-like symptoms, chest pains, cough, fever and pleurisy in May2021. The day after her shot she had a day of flu-like symptoms, as anticipated. These subsided, but a few days after that she was troubled with chest pains and a cough, and she worried that she might be having a cardiac event. She was sent to the ER, where they discovered she had a fever. They determined that she did not have COVID and cleared her for heart problems; they thought that she might be experiencing pleurisy. Her diagnosis ultimately was "chest pain, unspecified type. Patient did not receive any treatment. The patient underwent lab tests and procedures which included sars-cov-2 test: negative  on 10May2021. The outcome of flu-like symptoms was recovered in 2021. The outcome of the rest of the events was not recovered.   No follow-up attempts are possible. No further information is expected.
She felt lightheaded, then fainted and then had a brief seizure, (around 10 seconds.) She was post ictal for around 30 minutes. She completely recovered.
BACK PAIN; FEVER; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested.No concomitant medications were reported. On an unspecified date, the subject experienced back pain, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the back pain and fever was not reported. This report was non-serious.
fistula was bleeding for a couple of weeks; extreme lower back pain; lower back muscle spasms; This spontaneous case was reported by a consumer and describes the occurrence of ARTERIOVENOUS FISTULA SITE HAEMORRHAGE (fistula was bleeding for a couple of weeks), BACK PAIN (extreme lower back pain) and MUSCLE SPASMS (lower back muscle spasms) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 053E21A and 006B21A) for COVID-19 vaccination.     The patient's past medical history included Dialysis. Concurrent medical conditions included Immunocompromised and End stage renal disease.   On 29-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ARTERIOVENOUS FISTULA SITE HAEMORRHAGE (fistula was bleeding for a couple of weeks) (seriousness criterion medically significant), BACK PAIN (extreme lower back pain) (seriousness criterion medically significant) and MUSCLE SPASMS (lower back muscle spasms) (seriousness criterion medically significant). At the time of the report, ARTERIOVENOUS FISTULA SITE HAEMORRHAGE (fistula was bleeding for a couple of weeks), BACK PAIN (extreme lower back pain) and MUSCLE SPASMS (lower back muscle spasms) had not resolved.            The patient experienced slight fever after the second dose of Moderna. After the third dose (for/due to being immunocompromised) the patient experienced extreme lower back pain and muscle spasms. Narcotics did nothing, however, muscle relaxers and pain relievers did help but was still very bad. The patient was an end stage renal patient who does his dialysis treatments at home via a fistula. That fistula was bleeding for a couple of weeks and he had to have surgery on it today. The pain was so bad he had difficulty even going to the surgery.  Although very limited information has been provided at this time, based on the current available information and temporal association between the use of the product and the onset date of the events (likely exacerbation of fistula site bleeding post-vaccination with symptoms of excruciating low back pain and muscle spasms), a causal relationship cannot be excluded.   This case was linked to MOD-2021-304969.   Reporter did not allow further contact; Sender's Comments: Although very limited information has been provided at this time, based on the current available information and temporal association between the use of the product and the onset date of the events (likely exacerbation of fistula site bleeding post-vaccination with symptoms of excruciating low back pain and muscle spasms), a causal relationship cannot be excluded.
Patient describes that 2-3 days after receiving the vaccinations she started to notice her right arm was very red, warm to the touch, and itchy. She came back to me today and described that while on a long trip out of the country the red spot developed into a rash all over her body but she is better now and has no rash.
Delayed anaphylaxis after receiving the vaccine. Symptoms including hives, shortness of breath, and felt like her throat was closing. Her initial symptoms included hives which began 6 hours after receiving the vaccine. This eventually progressed to anaphylaxis and she went to the ED 2 days later.
Unspecified AEs after getting 2 Moderna shots; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (Unspecified AEs after getting 2 Moderna shots) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Unspecified AEs after getting 2 Moderna shots). At the time of the report, IMMUNISATION REACTION (Unspecified AEs after getting 2 Moderna shots) outcome was unknown.            No concomitant medications were provided.  It was reported that patient already got 2 Moderna vaccines and experienced AEs after getting both shots.  No treatment medications were provided.   Reporter did not allow further contact
This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Soreness on the left arm), MYALGIA (Arm very painful when lifted and stretched,Every part of the body neck down hurts,Felt like a truck hit), VACCINATION SITE ERYTHEMA (Redness on the injection area), VACCINATION SITE PRURITUS (slight Itch on the injection area) and HEADACHE (Bad Headache) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0461A21A and 001A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History Information was reported. On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Mar-2021, the patient experienced VACCINATION SITE PAIN (Soreness on the left arm). On 26-Mar-2021, the patient experienced MYALGIA (Arm very painful when lifted and stretched,Every part of the body neck down hurts,Felt like a truck hit), VACCINATION SITE ERYTHEMA (Redness on the injection area), VACCINATION SITE PRURITUS (slight Itch on the injection area), HEADACHE (Bad Headache), FATIGUE (Fatigue), DIZZINESS (Extreme Dizziness) and NAUSEA (Nausea). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] for Adverse event, at an unspecified dose and frequency. On 27-Mar-2021, MYALGIA (Arm very painful when lifted and stretched,Every part of the body neck down hurts,Felt like a truck hit), VACCINATION SITE ERYTHEMA (Redness on the injection area), VACCINATION SITE PRURITUS (slight Itch on the injection area), HEADACHE (Bad Headache), FATIGUE (Fatigue), DIZZINESS (Extreme Dizziness) and NAUSEA (Nausea) had resolved. On 01-Apr-2021, VACCINATION SITE PAIN (Soreness on the left arm) had resolved. No relevant Concomitant medications were reported. This case was linked to MOD-2021-048670. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 21-May-2021 and was forwarded to Moderna on 21-May-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Soreness on the left arm), MYALGIA (Arm very painful when lifted and stretched,Every part of the body neck down hurts,Felt like a truck hit), VACCINATION SITE ERYTHEMA (Redness on the injection area), VACCINATION SITE PRURITUS (slight Itch on the injection area) and HEADACHE (Bad Headache) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0461A21A and 001A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History Information was reported. No relevant Concomitant medications were reported. This case was linked to MOD-2021-048670.
Sudden onset of skin issues; Red itchy rash that calmed followed by white patches; Intensified by sunlight; vitiligo/calmed followed by white patches; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Nov2021 at 09:30 as dose 3 (booster), single (Lot number: FH8020) at the age of 62 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Chronic lymphocytic leukaemia" (unspecified if ongoing); "Known allergies: sulfa antibiotics" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN + HIDROCLOROTIAZIDA. Vaccination history included: BNT162b2 (Dose Number: 2, Batch/Lot No: EN6202, Location of injection: Arm Right, Vaccine Administration Time: 10:00 AM), administration date: 28Feb2021, for Covid-19 immunization; BNT162b2 (Dose Number: 1, Batch/Lot No: EL9263, Location of injection: Arm Right, Vaccine Administration Time: 10:00 AM), administration date: 25Feb2021, for Covid-19 immunization. The following information was reported: CONDITION AGGRAVATED (disability) with onset Feb2022, outcome "not recovered", described as "Intensified by sunlight"; RASH ERYTHEMATOUS (disability) with onset Feb2022, outcome "not recovered", described as "Red itchy rash that calmed followed by white patches"; SKIN DISORDER (disability) with onset Feb2022, outcome "not recovered", described as "Sudden onset of skin issues"; VITILIGO (disability) with onset Feb2022, outcome "not recovered", described as "vitiligo/calmed followed by white patches". The events "sudden onset of skin issues", "red itchy rash that calmed followed by white patches", "intensified by sunlight" and "vitiligo/calmed followed by white patches" required physician office visit.  Clinical course: Adverse event: Dr. suspects vitiligo. Adverse event start time: 06:00 AM. The patient did not receive any other vaccine in four weeks. Other medications in two weeks: Losartan- HCTZ 50-12.5. If covid prior vaccination: No. If covid tested post vaccination: No. The patient received fourth dose of BNT162b2 (Lot Number: FM0173) on 11Jul2022 at 10:00 AM, in right arm and fifth dose of BNT162b2 (Lot number: GJ2524) on 06Oct2022 at 09:15 AM, in left arm for Covid-19 immunization.
sore arm; diarrhea; sore rib; lump on neck; This is a spontaneous report from a contactable consumer. A 29-year-old female patient received the first dose of BNT162B2 (Pfizer-BIONTECH COVID-19 Vaccine; Lot number: Ek4176), via an unspecified route of administration in the left arm on 12Jan2021 at 16:45 as a single dose for COVID-19 immunisation. Medical history included hypothyroidism, PCOS (polycystic ovaries), and allergy to penicillin. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine, was not diagnosed with COVID-19 prior to vaccination, and was not pregnant at the time of vaccination. Concomitant medications included levothyroxine, metformin, and daily multivitamins (also reported as medication that the patient received within two weeks of vaccination). After the first dose, on 15Jan2021, the patient experienced sore arm, diarrhea starting day 3 through today, sore rib, and lump on neck. It was unknown if the events were treated. It was reported that the events resulted in a doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient has not been tested for COVID-19. Outcome of the events was recovering. The case was reported as non-serious (did not result in death, was not life-threatening, did not cause/prolong hospitalization, was not disabling/incapacitating, and did not result to any congenital anomaly/birth defect).
administered 1st dose of Moderna COVID-19 vaccine to 15 year old; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (administered 1st dose of Moderna COVID-19 vaccine to 15 year old) in a 15-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Aug-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (administered 1st dose of Moderna COVID-19 vaccine to 15 year old). On 30-Aug-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (administered 1st dose of Moderna COVID-19 vaccine to 15 year old) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product was not provided by the reporter. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 30-Aug-2021: follow-up received and no new information was provided.
My arm by the injection site got very red, warm, swollen and itchy.  But the area is large, red and not getting better. I got the vaccine a week ago tomorrow.  It doesn't seem to be improving at all.  Actually looks like it's getting worse. I may have to ask or go see a dr tomorrow. Wanted to know if this was a normal reaction to the vaccine or an allergic reaction.
I tested positive for Covid-19 on March 18, 2023, I experienced a sore throat, headache, I was taking Tylenol and was prescribed Paxlovid for my symptoms.
Information was received from a medical assistant who stated that multiple temperature excursions involving M-M-R II, took place from 20-FEB-2014 through 06-MAR-2014. Improperly stored vaccines of M-M-R II (batch #H017436, lot #0480AE, expiration date 29-AUG-2015; reported as expiration date of 20-SEP-2014), albumin status rHA, were administered to unspecified patients on unspecified dates (dosages and routes of administration were not provided). No adverse effects reported. Additional information has been requested.
I received the first dose Moderna, and it started off with left ear being plugged up and it wouldn?t clear subsequently I get a strong solid tone, I?ve gotten amplified sounds out of the left ear, If I?m watching tv the voice comes through in a burbling way and at times I?m watching tv straight ahead and the left ear hears the sound from the side and the right ear hears the tv. I have no other known reasons to suspect anything else to have caused the problems, the only thing I can relate the change to is having the two vaccinations.  I saw ENT an did a hearing test with significant loss of hearing in left ear and that was followed up with a basil endoscopy and no determination could be made from that. I?m scheduled for a brain scan on March 30th.