chrisvoncsefalvay/vaers-outcomes huggingface dataset:
2/6/2021    The day after my second Moderna vaccine shot. Woke up at 0300 feeling like I got hit by a Mack truck. Total body aches, especially the injection site on the right shoulder, the left shoulder at the old injection site (mirror pain?, Psychosomatic?, Real?), headache, jaw ache, sensitivity to light, stiffness and soreness in all muscles and joints, lethargy, no stuffy nose or congestion, but surprisingly no nausea/vomiting, instead I was super hungry.  All day this persisted. I was hungry but could only eat half portions at most. Finally, after dinner, the body aches and headache had subsided. Still super tired, still painful at the injection site. I spent most of the day wearing sweatpants and sweatshirt with the hood up either on the couch or in bed with the covers up, and no sweating. Had some chills and a mild fever that came and went. At night, while wearing only my underwear, after being asleep for only an hour or two, I woke up to extreme sweating. The sheets were soaked and we had to change them. My wife said I was dripping sweat like I had just finished running for an hour. Took a shower and went back to bed in just my underwear. Had a couple more episodes when I thought I might start the extreme sweating so I flipped the covers off for a few minutes each time so I wouldn?t overheat. It did not feel like I was overheating under the covers ? just felt like I was about to start sweating again. Weird.  2/7/2021    The second day after the vaccine shot. Feeling much better, but still lethargic. Woke up late around 1030. Had brunch. Took a shower, got dressed and had to go back to bed because of the tiredness. No more chills or fever. By the late afternoon and evening I was feeling mostly back to normal. Had a full sized, normal dinner. Slept well, in my underwear, no sweating, and no chills. 2/8/2021    The third day after the vaccine shot. Woke up feeling totally normal. Got in a good 18 mile bike ride and felt fine.
redness & induration noted @ inj site day p/vax;approx 2x3" size;warm to touch;pt c/o h/a given baby ASA;mom consulted w/pediatrician;advised to use warm compresses & massage site;
bleeding and excessively and that is not normal / my granddaughter is bleeding to death; My granddaughter is in the hospital, 6 years old, vaginal bleeding after taking your freaking product; she is now having period so heavy that she has to go to the hospital; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 6-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Flu vaccine (She had a flu vaccine a year ago but I don't blame the flu vaccine), for Immunization. The following information was reported: HAEMORRHAGE (hospitalization, medically significant), outcome "unknown", described as "bleeding and excessively and that is not normal / my granddaughter is bleeding to death"; VAGINAL HAEMORRHAGE (hospitalization), outcome "unknown", described as "My granddaughter is in the hospital, 6 years old, vaginal bleeding after taking your freaking product; she is now having period so heavy that she has to go to the hospital".  Clinical Course: Reporter stated that, no prior vaccinations within 4 weeks, she had a flu vaccine a year ago, but reporter don't blame the flu vaccine. No other medical conditions and concomitant medications, actually she was a perfectly healthy kid. She doesn't have to take anything. Reporter stated that, she was in the hospital. She took your shot and like thousand other girls, she started to bleed because of your shot. Every person that reporter had ever heard of (further clarifications unavailable, hence split not made), a female, who has taken your shot has had female problems and blood problems. No other conditions and other products.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Rash, facial swelling, lips swelling. Pt was given solumedrol and BENARYL IM
pt recvd vax SEP92 & 3 to 4 wks following vax exp pain in rt shoulder similar to that in the lt; treated self w/Advil; orthopod x-ray said that sounded as if had a rotater cuff problem;
Patient presented to the emergency department 9/18/2022 with chest pain and sudden onset difficulty speaking. Upon assessment he shows dysarthria, expressive aphasia, ataxia with right arm. CT negative for head bleed. Diagnosis ischemic stroke - transferred to higher level of care.
Pfizer-BioNTech COVID-19 Vaccine EUA  The vaccine was administered around 1:25 within 10 minutes I had tingling in my finger.  That was all & I was released.  At about 1:55 I noticed tingling in my cheek & lips on the left side...numbing like done at the dentist.  On the advice of a friend who is a nurse, I took Benedryl a few minutes later & drove back to the hospital to be observed.  It only stayed on the left side of my face.  My throat was not a concern at all.  I was released again around 2:15 after consulting with the Dr on call.  By 3:15 my lips were pretty much better but the cheek still had some numbing.  I took another Benedryl later that evening (probably about 8 or 9) It felt heavy through out the remainder of the day & into the next day.  But mid day the following day all symptoms were gone even the sore arm.
every bone and muscle in her body hurts, bad; every bone and muscle in her body hurts, bad; This is a spontaneous report from a contactable consumer reporting for herself. A 69-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number EL3249/expiration date: not provided), via an unspecified route of administration, on 16Jan2021 (at the age of 69 years old) as a single dose in the left arm for L121. Relevant medical history included lung cancer 10 or 11 years ago and she only has one lung that breathes well, pneumonitis due to radiation to her right lung which damaged the lining in her right lung, ongoing high cholesterol since 10 to 12 years ago, and high iron content due to simvastatin. Concomitant medication included simvastatin 20mg once daily orally since an unknown date for years, for high cholesterol. On 17Jan2021, the patient experienced every bone and muscle in her body hurts, bad and was worsened. The outcome of the events every bone and muscle in her body hurts, bad was not recovered.
Pt was given MMR #2 booster dose on 04/26/2002. Pt states that she noticed achy joints and sore arm at injection site on 04/28/2002. Pt returned to clinic on 04/29/2002 with report of 3x4cm erythema with drainage or discharge at the injection site. Pt states no increase in size since 04/27/2002.
Makes a fist and is unable to reopen it.  This intensified after the second vaccination.  Hand makes fist on it's on.
Developed red area, hardened bump Dr. checked injection area - pt to call tomorrow or we will call to check if area is getting better or worse.
I contracted COVID-19 on 4/25. Scratchy throat, low grade fever, fatigue, little cough, headache. Loss of taste and smell.
administered with the wrong diluent; administered with the wrong diluent; This case was reported by a pharmacist via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The pharmacist reported that a nurse at another facility inadvertently administered Shingrix powder (antigen) with the wrong diluent which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The powder component was mixed with sterile water. The reporter did not consented to follow-up.
Neuropathic flares; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of NEURALGIA (Neuropathic flares) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Neuropathy.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced NEURALGIA (Neuropathic flares). At the time of the report, NEURALGIA (Neuropathic flares) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. No treatment medications were reported.
I caught Covid and experienced symptoms of Covid shortly after getting my booster of the Pfizer vaccine. I started off with muscle aches, headache, fatigue in the first three days after November 14. By November 19, I was coughing, had a runny nose, and had chills and sweats and a low fever. On November 21/22, I tested positive for Covid. I had a scratchy throat that was itchy and sore, chills and sweats. But my low fever never became too noticeable on a thermometer or too big of a deal. My mom and dad caught Covid and their fevers easily topped 99.5 deg F or 0 deg F. Mom and Dad also got Covid Pfizer bivalent boosters. In the end, I felt too sick, so then I used soap at the gym to wash away the mucus that contains virus and spike protein. I felt better immediately natter washing my throat and with soap and water.  But then after that I noticed changes in my body?s gender embodiment. I feel like my body is more masculine, my voice is deeper, I have an Adam?s apple, and stuff is protruding from my vagina. My breasts got smaller too. And it feels weird but I don?t know if I should see a doctor to discuss stuff related to sex hormone levels. I feel like my sex organs may be damaged permanently
17 year old receive his 1st dose on 01apr2021.; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old receive his 1st dose on 01apr2021.) in a 17-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old receive his 1st dose on 01apr2021.). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old receive his 1st dose on 01apr2021.) had resolved. Not Provided      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 reported. No treatment medications were reported
Presented with SOB, + Covid 9/22; Admit 9/24 to ICU with Covid PNA room air; tx with 9/24 Maxipime, steroids, singulair, zinc started 9/26 Remdesivir , Zosyn started; O2 requirements:  admitted on room air; 9/26 4 LPM 9/27 Airvo 50L/80% ? Aspiration PNA as well; 9/28 O2 requirements increasing; DNR 10/4 Hospice care initiated 10/5 D/C home hospice
Shots were administered.  Pt said woke up this morning and left arm has some swelling.  I recommended that the patient take Benadryl capsules to help with reaction on 11/15/20
This literature marketed report has been received from the authors of a published literature article, and refers to a 39-month-old patient of unknown gender. The patient's concurrent condition included ataxia telangiectasia, reported as inherited immunodeficiency and cutaneous granuloma. The patient's medical history and concomitant medications were not reported. On unknown dates at age of 12 and 17 months, the patient was vaccinated with M-M-R II (dose, route of administration, lot# and expiration date were not reported) for prophylaxis. On an unknown date, the patient developed immunodeficiency-related vaccine-derived rubella virus (iVDRV). The patient had skin involvement that was described as initially psoriasiform or resembling pyoderma gangrenosum. The patient had chronic inflammation in skin where the rubella was detected by immunofluorescence or polymerase chain reaction (PCR). The Rubella capsid protein was detected and the iVDRV strain with multiple non-overlapping mutations was identified in the skin biopsy by sequencing viral genomes. The patient's CD3 count was 3074 cells/uL, CD4 count 2450 cells/uL, CD19 count 178 cells/uL and natural killer (NK) cell count 1158 cells/uL. The authors assessed CD3, CD4 and NK count as normal. The patient was treated with topical steroids, non-steroid anti-inflammatory drugs (NSAID) and intravenous immunoglobulin (IVIG) with no improvement. Nitazoxanide was used for 5 months, largely as salvage therapy in this extremely ill patient but it had no obvious benefit. Hematopoietic stem cell transplantation (HSCT) was performed with improvement in lesions. The authors considered the iVDRV to be related to M-M-R II. Upon internal review, the iVDRV was determined to be medically significant as the patient underwent the HSCT. This is one of seven reports derived from the same literature article (linked marrs# 1902USA004783, 1902USA003143, 1902USA004785 1902USA004786, 1902USA004787, 1902USA004788). Sender's Comments: US-009507513-1902USA003143:
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a elderly female patient who received SHINGRIX for prophylaxis. Previously administered products included influenza vaccine with an associated reaction of injection site pain (received in the past and had adverse event). On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additonal details were reported as follows: The patient was sister of the reporter. The age at vaccination was not reported. The patient experienced soreness at her injection site. Limited information was provided. The rpeorter did not want to provide additional demographics.
Wednesday, January 26, 2022, I noticed a small rash form on my right forearm. It later progressed to my whole forearm Friday, January 28th, morning. Large red welts and hives soon started to cover my whole body, including my face, legs, stomach, and back. The next day, Saturday, January 29th, the hives were covering my whole body, so I was taking oral Benadryl to help relieve the itching, I went to the ER for treatment as the welts were becoming unbearably itchy and uncomfortable where I was given IV Benadryl, Pepcid, and solumedrol to counteract the hives, this was at 12:30 am Sunday the 30th. The IV medication only helped for a few hours and I was back to being covered in hives and welts. Wednesday February 1st, I went ot the clinic to be seen for the rash and was given a rapid COVID test which was negative. Blood was taken for tests and I am waiting for results. I am currently on prednisone and hydroxyzine.
Severe chills, extreme sweating, nausea, vomiting, weakness, fatigue, loss of sleep, body aches, headache off and on for 17 consecutive hours. Side effects began to subside around 3 PM 02/28/2021. Some swelling of mouth and tongue and general fatigue continued until 03/05/2021, then gradually went away.
One hour after receiving Hep B, pt returned to school clinic complaining with headache and nausea. Pt has hx of HA). Nurse gave pt an extra strength Tylenol. Mother of pt called, pt and mother went to counselor's office. Pt began to shake. Mother took pt to clinic to see MD who admitted pt for one night. Pt back at school on 8/22/02.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: ESTRADIOL.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course: Patient received other medication in 2weeks. No known allergies. The patient received anti viral product from 28Nov2022 to 02Dec2022 for treatment of COVID-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
She developed a swollen tongue within hours after the vaccine but woke her from sleep 16 hours post vaccine with significant swollen tongue. Did not go to ER but called our office the next morning.
Pt developed a raised red area on back of Left arm on Sunday, 4/26 after immunization on 4/16.  Area was hot and itchy when noticed.  Presented @ clinic on 4/28, area increased in size (approx. 50 mm X 50 mm)red, hot to touch with darker area posterior and distal (approx. 10mm X 10mm).  Pt c/o tingling down arm.  Per followup phone call to patient--patient was seen at Urgen Care clinic and given diagnosis of cellulitis that was not related to the varicella injection.  Patient states she was treated with Zithromax with improvement of symptoms.
Severe joint and muscle pain in right hip area- radiating down the right leg; Severe pain in left neck, shoulder and scapula; Unable to carry out normal daily activities.
This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itching at injection site), VACCINATION SITE ERYTHEMA (Redness at injection site), VACCINATION SITE SWELLING (Swelling at the injection site) and VACCINATION SITE PAIN (Pain at injection site) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination. The patient's past medical history included No adverse event (No recorded medical history). On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Itching at injection site), VACCINATION SITE ERYTHEMA (Redness at injection site), VACCINATION SITE SWELLING (Swelling at the injection site) and VACCINATION SITE PAIN (Pain at injection site). On 09-Jan-2021, VACCINATION SITE PRURITUS (Itching at injection site) and VACCINATION SITE PAIN (Pain at injection site) had resolved. At the time of the report, VACCINATION SITE ERYTHEMA (Redness at injection site) had not resolved and VACCINATION SITE SWELLING (Swelling at the injection site) was resolving. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant product use was not provided by the reporter. Treatment information was not provided. Company comment:Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Most recent FOLLOW-UP information incorporated above includes: On 15-Apr-2021: NNI; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Hotness at the injection site; Redness at the injection site; Itching at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE WARMTH (Hotness at the injection site), INJECTION SITE PRURITUS (Itching at the injection site) and INJECTION SITE ERYTHEMA (Redness at the injection site) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), MAGNESIUM OXIDE (MAGNESIUM OXIDE 400), ATORVASTATIN CALCIUM (LIPITOR), OMEPRAZOLE, Vitamin D and CETIRIZINE HYDROCHLORIDE (ZYRTEC) for an unknown indication.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, the patient experienced INJECTION SITE PRURITUS (Itching at the injection site). On 13-Feb-2021, the patient experienced INJECTION SITE WARMTH (Hotness at the injection site) and INJECTION SITE ERYTHEMA (Redness at the injection site). At the time of the report, INJECTION SITE WARMTH (Hotness at the injection site) and INJECTION SITE ERYTHEMA (Redness at the injection site) outcome was unknown and INJECTION SITE PRURITUS (Itching at the injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was provided by the reporter as allergy shots every 2 weeks. Treatment information was provided as Triamcinolone 0.1%.
admitted  to Medical Center and Covid-19 posititive on  5.29.2023, expired 5.31.2023