chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case reported by a patient, describes the occurrence of peripheral swelling (arm swelling after each dose) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 008B21A) for COVID-19 immunization. No medical history reported. On Apr 20, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On an unknown date, patient experienced peripheral swelling (arm swelling after each dose). At the time of the report, peripheral swelling (arm swelling after each dose) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular): unknown. No concomitant medication or treatment information reported. This case linked to MOD-2021-281237 (patient link).
Case number PHEH2014US019764 is an initial spontaneous report from the consumer received on 01 Oct 2014. This report refers to a 68-year-old female patient. She was vaccinated with FLUVIRIN (batch number: not reported) intramuscularly on an unknown date. On 21 Oct 2013, couple of hours after vaccination her injection site got itchy. At end of the day, her arm felt hot and had a large red circle. When she went to bed at night her arm from her elbow to shoulder was purple/red. She also had lump at the injection site. It was reported that the event redness went away 3 days later and event lump at injection site was still ongoing. The outcome of the remaining events was not reported. The seriousness and causality of the events were not reported.
Three doses of Pfizer COVID-19 vaccine were administered as an unauthorized third dose or "booster" on 8/6/21 to hospital employees. We are considering this an "administration error" as the third dose was not authorized for these individuals under the EUA.
12 hours after injection, sever chills, shaking temp of 99.8 at 0400 hrs., slight headache, dizzy.
I had the injection site pain; pain in the arm; muscle pain; tired; slight headache; slight chills; slightly below my normal capacity to get out and do things; I didn't sleep that night; This is a spontaneous report received from a contactable consumer (patient). An 81-year-old female patient received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on an unspecified date and dose 2 of BNT162B2 (lot number EN6203) on 04Apr2021 in midafternoon; both via unspecified routes of administration as single doses for COVID-19 immunization. Medical history and concomitant medications were not reported. With both doses of BNT162B2 the patient had the same reactions. The first 24 hours the patient had injection site pain, pain in the arm, muscle pain, and she didn't sleep that night. Within the 24 hours she was a little more tired than usual with a slight headache, slight chills, and no other adverse reaction. The patient had no fever, no swelling, no nausea. She felt okay but slightly below her normal capacity to get out and do things. The outcomes of injection site pain, pain in the arm, muscle pain, didn't sleep that night, a little more tired than usual, slight headache, slight chills, and slightly below her normal capacity to get out and do things were unknown.  No follow-up attempts are needed. No further information is expected.
On waking, he experienced pain in left arm and shoulder.  After a month still has some numbness and tingling in left arm and hand.
Sore arm; Tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and FATIGUE (Tired) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007cz1a) for COVID-19 vaccination.     Concurrent medical conditions included Sulfonamide allergy, Drug allergy (Neosprin) and Adhesive tape allergy. Concomitant products included FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]) for Allergy, ETHINYLESTRADIOL, NORETHISTERONE ACETATE (JUNEL) for Birth control, ASCORBIC ACID, VACCINIUM MACROCARPON (CRANBERRY [ASCORBIC ACID;VACCINIUM MACROCARPON]) for Urine analysis, BIFIDOBACTERIUM INFANTIS, LACTOBACILLUS ACIDOPHILUS (PROBIOTIC [BIFIDOBACTERIUM INFANTIS;LACTOBACILLUS ACIDOPHILUS]) and FISH OIL for an unknown indication, DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (TDAP).    On 25-Apr-2021 at 12:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Apr-2021, the patient experienced PAIN IN EXTREMITY (Sore arm) and FATIGUE (Tired). On 30-Apr-2021, PAIN IN EXTREMITY (Sore arm) and FATIGUE (Tired) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment medication were not reported.  The patient was taking Probiotic for healthy bacteria, Cranberry for urinary support and Fish oil for healthy heart. The patient noticed sleep helped a lot for her to felt better.   This case was linked to MOD-2021-403106, MOD-2021-403163 (Patient Link).
body aches; fever; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (body aches), PYREXIA (fever) and FATIGUE (fatigue) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M20A and 011J20A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma and Enlarged prostate. Concomitant products included MONTELUKAST and FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR) for Asthma, TAMSULOSIN for Enlarged prostate, NAPROXEN for an unknown indication.   On 27-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN (body aches), PYREXIA (fever) and FATIGUE (fatigue). At the time of the report, PAIN (body aches), PYREXIA (fever) and FATIGUE (fatigue) outcome was unknown.            No treatment medication details was reported.
swelling in upper and low lips and right hand after second dose; swelling in upper and low lips and right hand after second dose; This is the spontaneous report from a contactable consumer (patient). A 39-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Solution for injection), via an unspecified route of administration, administered in the left arm, on 08Feb2021 (Batch/lot number: EL3302), at age 38 years old, as dose 2, single, for COVID-19 immunisation, at a workplace clinic. The patient was not pregnant at the time of vaccination. Relevant medical history included gastroesophageal reflux disease (GERD), obesity, temporomandibular joint (TMJ), cameron ulcers, hiatal hernia, and known allergies to sulfa, dust, and some roots, all from unknown dates, not reported if ongoing or not. The patient did not have COVID-19 prior to vaccination and was not tested for COVID-19 post vaccination. Concomitant medication included omeprazole taken for an unknown indication, start and stop dates not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Solution for injection), received via an unspecified route of administration, administered in the left arm, on 18Jan2021 08:30 (Batch/lot number: EL3302), at age 38 years old, as dose 1, single for COVID-19 immunisation after which the patient experienced swelling in lower lip. The patient did not receive any other vaccine in four weeks. On an unspecified date, the patient experienced swelling in upper and low lips and right hand after the second dose. The events resulted to physician's office visit. Treatment included BENADRYL which did not help and prednisone which helped. The patient recovered from the events on an unspecified date.  No follow-up attempts are needed. No further information is expected.
Uncontrolable crying high pitched.  Using motrin every 6 hours.  Not eating, not sleeping, unconsolable.
I developed severe body wide urticaria. It is unclear whether or not this is a delayed reaction to the vaccine or secondary to a new onset food allergy. It was responsive to cetirizine and lasted for about six to eight hours with severe pruritus but no airway symptoms.
Kinrix instead of Pediarix; 4 months old patient received Kinrix; This case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 4-month-old female patient who received DTPa-IPV (Kinrix) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 8th June 2022, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 8th June 2022, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced wrong vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the wrong vaccine administered and inappropriate age at vaccine administration were 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: 14-Jul-2022. Reporter's Comments: Nurse reported that a 4 months patient received a Kinrix vaccine instead of Pediarix. This was a second dose of Dtap shot. The reporter consent to follow up by mail. Additional supportive information: The four months old patient was given Kinrix instead of Pediarix which led to wrong vaccine administered and inappropriate age at vaccine administration.
Patient without prior otologic history noted right sudden SNHL ~5-6 weeks after vaccination. No associated vertigo, aural fullness or tinnitus.
Patient states that arm has been sore to use since receiving the vaccine; NO redness, rash, warmth to touch or lump or swelling; she states it is sore upon waking in the morning and the stiffness lesses slightly as the day progresses but is sore all day sometimes she has issues gripping & moving arm front to back but not as much soreness raising arm upwards; she was advised by her prescriber to have pharmacy report
After receiving FLUZONE HD, patient felt as she had the flu. She is normally healthy and has not been in contact with other sick people. She had a fever and has been very achy. Resolved after 1 week.
Days after vaccination I developed an acne outbreak that in both number and locations across my body almost resembles chickenpox
Patient presented 4/28/2021 for second Moderna Covid 19 vaccine.  Patient stated that since her first dose of Moderna Covid 19 vaccine on 3/30/2021 she "could not taste anything".
This spontaneous report has been received from a physician referring to a patient of unknown age and gender. No concurrent or historical condition was reported. On 07-JUL-2015 the patient was vaccinated with an improperly stored dose of GARDASIL dose, route, frequency, Lot number and anatomical location were unknown. No adverse event was reported. This is one of several cases received from the same source. Additional information has been requested.
Patient developed rash on 3/8/21 two days following covid 19 vaccination. Red, patches, pruritic encompassing chest, back, legs, arms, and abdomen (sparing face, palms, and soles). Dermatology stated on prednisone 20mg daily to help. Due to progression, patient presented to medical center on 3/19/21. Rash appeared to have some pustules and desquamation.  Also, had some swelling and pain to the areas. Dermatology biopsies on 3/20/21 which showed findings consistent with drug eruption. Rash began to improve on 3/23/21 and patient was discharged home with continued Triamcinolone cream for presumed acute generalized exanthematous pustulosis.
! 11PM started running fever; acted restless; about 2AM c/o h/a & stomachache; t102.6; given APAP & tepid bath; p/bath c/o throat hurting & vomited; taken to MD & given fever meds;
I have a 3? by 2? welt where the injection was. It went away  when I first had it but now it?s back and itches a tad.
Hello, I want to notify you about that outcome of my Covid #4 vaccination in hospital. I received a Pfizer - BioNTech 30 mcg/ 0.3 ml BIVALENT BOOSTER PF, MDV vaccine Lot# GH9703 on Oct 25th, 20022 at Employee Occupation Health. I had a vaccination at 1315. My side effect was shivering from sudden chills that started that some evening after 1145 PM, which accompanied with body aches and muscle pain in all body. Could not get warm even with sweatshirt and socks in bed + blankets. The chills were nonstop the whole night. 103 F and headache, pain in eyelids if I look left or right. I could look only straight ahead. Took Ibuprophen around 4am. In the morning I stood up from bed to go to the kitchen, I could not walk straight, my back was 45 degrees, I could not get my back straight, it was parallel to floor. Was very week, did not have a strengths to straighten up my back, everything was so hurting. Had to miss the work that next morning. The day after, the temperature was 100 F, the chills were persistent, but less shaky, still had the headache and dizziness if I turn my head up and down in the bed. I was miserable. Thank you.
Have had some chest pain for a few days and different breathing.   Doesn?t feel like my normal breathing  just feels more restrictive than normal.
12/31 8:30am noticed maculopapular erythematous rash mostly on torso (few lesions on extremities), itchy scalp, and mild edema/erythema at RT corner of bottom lip. Also had mild pain on ball of RT foot, thought I had stepped on something. 1:30pm woke up with severe edema of bottom lip, rash also on scalp next to ears 3pm seen at urgent care, received and filled prednisone prescription  4pm lip edema started improving, so did not end up taking the prednisone 8pm lip edema gone, erythema and mild edema to DIP joint and tips of fingers, all fingers of LT hand and RT pinky. All hand joints and wrists sore. Soreness to toes and heels while walking but not at rest. Applied ice to fingers, then turned up heat. 1/1 3-4am finger edema/erythema totally resolved 8am foot pain starts resolving 5pm still with mild wrist pain, mild foot pain. Rash evolving -- most lesions improved but some have coalesced, new lesions on neck  Never any fever, checked x2, Tmax 99.0F. Did not end up taking any medications since my symptoms seemed to be resolving. Only other possible recent exposures were a new lotion tried 12/27 (but only applied to face, was careful to keep it away from my lips, and I did not have any rash on my face except the swollen lip) and a new dress that I did not pre-wash (but I had few lesions on my arms which would have also been exposed).
I received my first shot of Moderna on August 19, 2021.  About a week after receiving my FIRST shot of Moderna, I started getting spontaneous bruising in different places all over my body.  Some were large, some were small.  I also had small red/purple dots in patterns all of my body (Petechia).  I was EXTREMELY fatigued with a continuous slight headache and just felt like something wasn't right. On August 31, I called my doctor to have them order me a blood panel.  My platelet counts had dropped to 50 and I was sent directly to the emergency room.  Lots of blood tests and a CT scan was performed.  I was diagnosed with THROMBOCYTOPENIA and am now waiting to see a hematologist.  I was put on a round of Prednisone for 5 days.  My numbers are slowly climbing back up, but they still are below normal.  On Sept. 3rd, my platelet count was at 147 which is still NOT Normal.
I had no AE to the vaccine, but on 6/15 I started feeling like I couldn't catch my breath.  I begin having diarrhea with no pain associated and was extremely tired so on 6/22 I took a COVID test, and it was positive resulting in me sleeping about 3 days and all symptoms subsided a few days later.  Later on, 12/21 I woke up with a scratchy throat and pain in my throat area.  12/23 I took an at home COVID test, but it was negative.  But because I slept from 12/20-24 only getting up to eat slightly and sleeping the rest of the time.  And severe body aches and chills.   I tried to make myself get up and move around several times, but I was still so tired and sluggish this time resulting in me sleeping more about 12 hours a day from 12/27-12/28, so I went to see my PCP and another COVID test was performed on 12/29 and it was positive this time as well.  My head was hurting so bad causing extreme pain in my right ear.  My ear felt as if it was going to explode and felt stuffed up, so my PCP prescribed an Antibiotic for that.  I am still having a lingering cough and a mild ear stoppage type feeling but our Cedar count is like 3000 so that could also be affecting it as well
pt recv 3 doses of vax FEB93, MAR93 & AUG93;in 1997 pt dx w/a non-malignant lump in the testicle which was attributed to spontaneous growth r/t connective tissue disorder;the testicle was removed;
Within 1/2 hour of vaccine administration c/o pins and needles in fingers and arms and had difficulty breathing seen by Dr in Medical clinic recieved 50 mg of Benedryl and 40 mg of oral Prednisone and had a nebulizer treatment.  Breathing improved but still c/o feeling very tired and "like I was run over by a truck".  Employee has a history of asthma and recieves allergy shots.  Also stated that the counts for pollen and ragwood are very high today and has never taken flu vaccine this early (has taken it for past 20 years).  Reports that the only other time she had a similiar reaction was several years ago when she took it this time in the early fall and not waited for a couple of good frosts to lower the pollen//ragweed counts.
Mild soreness on left arm within a few hours of receiving the shot; Felt chilled that evening and again in the morning, although there was no fever; General ill feeling reminiscent of the feeling experienced after a fever breaks; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 40 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 24Mar2021 14:00 (Lot number: EP6955) at the age of 40 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Erectile dysfunction" (unspecified if ongoing). Concomitant medication(s) included: VITAMIN D3; TADALAFIL; FISH OIL; GARLIC EXTRACT [ALLIUM SATIVUM BULB]. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 24Mar2021 14:30, outcome "recovering", described as "Mild soreness on left arm within a few hours of receiving the shot"; CHILLS (non-serious) with onset 24Mar2021 14:30, outcome "recovering", described as "Felt chilled that evening and again in the morning, although there was no fever"; MALAISE (non-serious) with onset 24Mar2021 14:30, outcome "recovering", described as "General ill feeling reminiscent of the feeling experienced after a fever breaks". Therapeutic measures were not taken as a result of pain in extremity, chills, malaise.  Additional information: COVID-19 vaccine was administered at the facility of workplace clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. List of other medications the patient received within 2 weeks of vaccination include fish oil, vitamin D3, multi-vitamin, tadalafil, garlic extract. No known allergies. Patient had no allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
temperature of 102°F ,then following 2 days they have temperature of 100°F; really fatigued,They are still really fatigued; felt like something was sitting on their chest; This spontaneous case was reported by a consumer and describes the occurrence of BODY TEMPERATURE INCREASED (temperature of 102°F ,then following 2 days they have temperature of 100°F), FATIGUE (really fatigued,They are still really fatigued) and CHEST DISCOMFORT (felt like something was sitting on their chest) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     Concomitant products included IBUPROFEN for an unknown indication.    On 28-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jun-2021, the patient experienced BODY TEMPERATURE INCREASED (temperature of 102°F ,then following 2 days they have temperature of 100°F), FATIGUE (really fatigued,They are still really fatigued) and CHEST DISCOMFORT (felt like something was sitting on their chest). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. On 01-Jul-2021, BODY TEMPERATURE INCREASED (temperature of 102°F ,then following 2 days they have temperature of 100°F) had resolved. At the time of the report, FATIGUE (really fatigued,They are still really fatigued) and CHEST DISCOMFORT (felt like something was sitting on their chest) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
6/2, temp 102 and weakness and headache and muscle spasms in legs and cramps, 6/3 to ER, discharged (virus) and 6/5 to ER, discharged (virus).
Got uncontrollable shakes, freezing, fever peaked at 103.4 and was all over the place for the following days.  I avoided going to the ER for fear of Covid.  Lasted nearly a week.  For first couple of days was assumed by MDs to be a reaction to vaccine but was diagnosed on Monday with a kidney infection.  Took five more days with antibiotics to get rid of fever and weeks to feel "normal."  Another person I know who got Moderna at same facility the previous week got a kidney infection in the following days.  Possibly coincidence but worth investigating.
tested positive on Aug 2.; tested positive on Aug 2.; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received first dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- ER8727) via an unspecified route of administration on 27Mar2021 as dose 1 single and received second dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EW0162) via an unspecified route of administration on 17Apr2021 as dose 2 single for COVID-19 immunization. Medical history and concomitant medications were not reported. Facility where the most recent COVID-19 vaccine was administered was other. 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. Patient presented with sore throat, headache and coughing on 31Jul2021 and tested positive on 02Aug2021. The adverse event result in Doctor or other healthcare professional office/clinic visit. No treatment was received for the adverse event. Hospitalization prolonged was no. Traveling companion was tested positive 30Jul2021. Since the vaccination, the patient had been tested for COVID-19 (sars-cov-2 test) via Nasal Swab which revealed negative on 28Jul2021 and positive 02Aug2021. The outcome of the event was recovered on an unspecified date in 2021.  Follow-up attempts are completed. No further information is expected.
Given flu vaccine and found out later that patient had already received flu vaccine on 10/13/2022.