chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pain and soreness in the right arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Pain and soreness in the right arm) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jan-2021, the patient experienced VACCINATION SITE PAIN (Pain and soreness in the right arm). At the time of the report, VACCINATION SITE PAIN (Pain and soreness in the right arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not reported.; 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.
Increased side effects, body aches, fever, lethargy lingering past normal time frame then seen for pneumonia.
Day 8 - "Covid arm" started (left arm only); fading on day 11 - treated only with tylenol and cortizone cream Day 11 - hives on both arms - currently treating with oral Benadryl
Injection IM not subcutaneous and patient had swelling with outbreak of shingles on left arm.
Arm was a little sore at injection site on 12/30/20, day of injection. Woke up 12/31/20 and had a nickel-sized lump/redness. Lump lasted about 2 days then disappeared on 1/3/21. On 1/7/21 axilla was tender and occasionally painful, On 1/8/21 lump and tenderness returned to injection site at 1:00pm. At 6:30pm that day site had a 50 cent piece lump which was red, raised and warm. Took Benadryl. Area was slightly more red and tender am of 1/9/21. so called MD and antibiotic ordered. Arm is slowly improving each day. Axilla is still painful. Had a similar reaction to Tdap 20 years ago which was treated as cellulitis. No known hx. of COVID, but had classic COVID symptoms in December when she tested negative.
20AUG devel back pain, 21AUG dx: pulled muscle, 22AUG t102 until 25AUG, loss of appetite & neck pain; 24AUG no abnormal lab test;
Pt called and stated that he received the shingles vaccination 01/11/16 and felt fine on Monday but Tue evening and Wed, started to not feel well.  Stated that he felt achy all over like he was getting the flu.  Also stated that at the injection site, it is red, warm to touch, and one blister in the area of the injection site.  Stated that it is a little itchy but no pain at this time.  Advised that the shingles vaccination is a live virus and is possible to have this reaction.  Advised to not pop the blister due to the possibility of it spreading.  Pt stated that today he feels much better. Pt asked what he could use for the itching.  Recommended Benadryl Cream.  Advised to monitor and if no improvement or if symptoms worsen to call our office.
p/vax pt exp fussy, irritable, 11/2-2 weeks; blood w/stool x2 7days p/vax;
Patient described burning and tingling in right arm down to fingertips that lasted about 10 minutes.  Symptoms resolved without intervention.
Per patient her "family has a history of passing out when receiving vaccines. Per patient she knew in her gut to mention but did not mention. This would be her first time. Syncope episode
On Jan 10th I experienced major headaches and sore throat and then the following day I felt nauseated so I took a home covid test and tested positive.  The following day I took a covid test at the doctor and also game back positive.  It the days to follow I had fever, vomiting, headaches, body aches, covid made me bleed extra heavy on my period because my blood was having a hard time clotting.
7cm area of redness & pain @ inject site; mother states foot was red & lt thigh swollen upon pt awakening; no evidence @ time of visit;
These events were reported by mother 3/19/04 left arm become quite swollen and sore. Developed hives & wheezing. Pt history of asthma. Mother treated with Benadryl and Albuteral. Child reportedly did well after that.
Information has been received from a healthcare worker concerning a 76 year old male patient with allergic reaction KEFLEX, CIPRO, sulfa and niacin and no pertinent medical history who in 2004 was intramuscularly vaccinated with 0.5 mL of the first dose of PNEUMOVAX 23 (Lot# and expiration not reported) and on 23-MAY-2011 was intramuscularly vaccinated with 0.5 mL of the second dose of PNEUMOVAX 23 (Lot# 670503/0386AA, expiration not reported). Concomitant therapy included COUMADIN, Lisinopril (manufacturer unknown), LUNESTA, omeprazole, TRAVATAN 004% and ezetimibe (MSD). It was reported that on 24-MAY-2011 after received the second dose of PNEUMOVAX 23 the patient experienced acute swelling on the upper arm of the right bicep area and arrhythmia. It was unknown if was unknown if the patient experienced any problems after received the first dose of PNEUMOVAX 23 in 2004. The patient sought medical attention by an office visit. A Doppler to rule out DVT-found to be negative was performed. BIAXIN 500 mg every 12 hours for 7 days was given as treatment for the adverse event. At the time of reporting the patient was recovering. Additional information has been requested.
A covid vaccine vial was reconstituted twice, this patient received a diluted dose of the vaccine, the patient was contacted about the issue, and the patient to come into to be revaccinated.
Fever 105, body aches and pain all over body, chills , shivering, nausea lasted for hours as well as , shortness of breath, weakness, fatigue, insomnia
Vaccine was administered patient on 05/10/2022.  As per manufacturer expiry date of vaccine was 07/08/2022 but beyond use date was 04/21/22.  Contacted the patient and patient has no adverse reaction due to vaccine.  There was no temperature excursion during storage of vaccine since vaccine was received at pharmacy.
Stiffness on left side of neck; swelling of the throat; difficulty breathing and swallowing; difficulty breathing and swallowing; face bright red; received dose 3; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 18Dec2021 02:45 (Lot number: FO7218) at the age of 45 years as dose 3 (booster), single for covid-19 immunisation in Drive thru vaccination clinic. The patient was not pregnant when administration. Relevant medical history included: "known allergies: Tree nuts" (unspecified if ongoing). No other medical history. Concomitant medication(s) included: VITAMIN D [COLECALCIFEROL] was received within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Past drug history included: Doxycyline, reaction(s): "known allergies: doxycyline". Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EW0171, Location of injection: Arm Left, Vaccine Administration Time: 10:00 AM), administration date: 23Apr2021, when the patient was 45 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EW0150, Location of injection: Arm Left, Vaccine Administration Time: 01:00 PM), administration date: 02Apr2021, when the patient was 45 years old, for COVID-19 Immunization. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination. The following information was reported: IMMUNISATION (life threatening) with onset 18Dec2021 02:45, outcome "unknown", described as "received dose 3"; MUSCULOSKELETAL STIFFNESS (life threatening) with onset 18Dec2021 15:00, outcome "recovered" (18Dec2021), described as "Stiffness on left side of neck"; PHARYNGEAL SWELLING (life threatening) with onset 18Dec2021 15:00, outcome "recovered" (18Dec2021), described as "swelling of the throat"; DYSPNOEA (life threatening), DYSPHAGIA (life threatening) all with onset 18Dec2021 15:00, outcome "recovered" (18Dec2021) and all described as "difficulty breathing and swallowing"; ERYTHEMA (life threatening) with onset 18Dec2021 15:00, outcome "recovered" (18Dec2021), described as "face bright red". Therapeutic measures (Epi pen, benedryl) were taken as a result of musculoskeletal stiffness, pharyngeal swelling, dyspnoea, dysphagia, erythema. The events resulted in life threatening illness (immediate risk of death from the event). The events were reported as serious. Seriousness criteria-Results in death: No. Seriousness criteria-Life threatening: Yes. Seriousness criteria-Caused/prolonged hospitalization: No. Seriousness criteria-Disabling/Incapacitating: No. Seriousness criteria-Congenital anomaly/birth defect: No.   Follow-up attempts are completed. No further information is expected.
Pain, swelling, increased warmth over site of injection (right deltoid.  Seen approximately 24 hours after administration and signs improved, but present yet.  Treated with ice compresses and acetaminophen.
right arm started tingling about 15 minutes after vaccine. Rash started on left wrist/forearm area. Took Benadryl and Zyrtec...symptoms subsided.
COUGH; SLIGHT ARM SORENESS; WEAKNESS/REALLY WEAK; HEADACHES EXCRUCIATING AFTER THE VACCINE; FEVER; SORE THROAT; COVID EYES; POST NASAL DRIP; This spontaneous report received from a consumer concerned a 64 year old male. The patient's height, and weight were not reported. The patient's past medical history included covid. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 02-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 2021, the subject experienced post nasal drip. On 02-APR-2021, the subject experienced sore throat. On 02-APR-2021, the subject experienced covid eyes. On 02-APR-2021, the subject experienced cough. On 02-APR-2021, the subject experienced slight arm soreness. On 02-APR-2021, the subject experienced weakness/really weak. On 02-APR-2021, the subject experienced headaches excruciating after the vaccine. On 02-APR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 101 F. The action taken with covid-19 vaccine  was not applicable. The patient recovered from sore throat, covid eyes, cough, and fever on 06-APR-2021, and slight arm soreness on 04-APR-2021, was recovering from weakness/really weak, and headaches excruciating after the vaccine, and the outcome of post nasal drip was not reported. This report was non-serious. This case, from the same reporter is linked to 20210545446.
pt recv one dose for prophylaxis; w/in 24 hr exp nausea; w/in 48 hr exp vertigo; recovered w/in 3 days
All over rash and hives and itching on body including face around eyes and mouth, scalp itching and tongue feeling funny at times but no swelling as far as I can tell. As of 04/09/2021 I have started taken Benadryl  in hopes that would help.  A little headache here and there.  Have taken Tylenol for that.
stopped breathing; "every bone in my body had been hit by a truck to the site of the road"; low grade fever; she received her booster dose last Friday and got extremely sick again from that; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Comirnaty (Dose: 1, Caller stated she "became extremely sick" from her first 2 shots of the Comirnaty vaccine), for Covid-19 Immunization, reaction(s): "Extremeely sick"; Comirnaty (Dose: 2, Caller stated she "became extremely sick" from her first 2 shots of the Comirnaty vaccine), for Covid-19 Immunization, reaction(s): "Extremeely sick". The following information was reported: RESPIRATORY ARREST (medically significant), outcome "unknown", described as "stopped breathing"; PAIN (non-serious), outcome "unknown", described as ""every bone in my body had been hit by a truck to the site of the road""; PYREXIA (non-serious), outcome "unknown", described as "low grade fever"; ILLNESS (non-serious), outcome "unknown", described as "she received her booster dose last Friday and got extremely sick again from that". The patient underwent the following laboratory tests and procedures: body temperature: low, notes: She also had low grade fever. Therapeutic measures were taken as a result of respiratory arrest, pain. Clinical Course: The patient wanted to know "how long the booster dose is good for after its manufacturing date on the vial." The patient said the date on the Comirnaty vial was 21Sep2021 and she just wanted to make sure that what she received isn't expired. The patient also said she isn't sure what formulation she received but it should be the grey cap as it does not need to be mixed. The patient reported that she "became extremely sick" from her first 2 shots of the Comirnaty vaccine. The patient said she received her booster dose last Friday and got extremely sick again from that. The patient mentioned she had stopped breathing but good thing she had an EpiPen. She mentioned that she felt like "every bone in my body had been hit by a truck to the site of the road" and that she also had low grade fever. The patient also mentioned she wasn't aware that she can get the booster dose after 5 months from her last dose so she waited for 6 months. She said yesterday would have been 6 months from her last shot. The patient also said that she took Advil after getting the booster dose and said that the "pain was bad this time but not as bad as before because of the Advil."  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Swelling/redness right upper arm from shoulder to elbow with 2 nickel-sized blisters present at top portion of area; presented to office 2/20/2019 at 1:00pm; given instructions to take KEFLEX susp 250mg/5ml: 10mls po q 8hrs x 10days; follow-up in office 24-48 hrs.
t101-102 for 24-36 hrs along w/poor feeding, crying, insomnia, very irritable;
Lump - above left collar bone at base of neck; approximately half an inch in diameter; mild tenderness; no change in size or tenderness in last 48 hours; no treatment; no impact on ability to work or function
First shingles vaccine 10/2019. She later had hand surgery; This case was reported by a consumer and described the occurrence of hand operation in a 82-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In October 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced hand operation. On an unknown date, the outcome of the hand operation was unknown.   It was unknown if the reporter considered the hand operation to be related to Shingrix.  Additional details were provided as follows: This case was reported by patient herself. The patient received 1st dose of Shingle vaccine and later had had surgery. The reporter consented to follow up. For tolerance of 2nd dose refer case US2021AMR087889. This case has been linked with US2021086467, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021086467:Same reporter US-GLAXOSMITHKLINE-US2021AMR087889:Same reporter.
On April 30th I hosted a group of children in my home, when I was then exposed to Covid 19. I then tested positive a few days after they had left on May 6th. I experienced fatigue with a sore throat that felt like strep. I also had a slight headache and chills that lasted about two days. I tested negative around the 7th day and felt 100% better.
Pt came to pharmacy complaining redness and soreness at injection site. C/o itching. Explained to pt to apply cold compresses and take ibuprofen and possibly BENADRYL.
Redness on injection stie; Pain on injection site; Soreness on injection site; A report was received from a consumer concerning a 48-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced a vaccine injection site with pain, soreness and redness.   The patient's medical history and relevant concomitant medications were not reported.   On 24-Dec-2020, approximately one day prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the right arm for prophylaxis of COVID-19 infection.   On 25-Dec-2020 the patient experienced injection site soreness and pain.  On 01-Jan-2021, the patient experienced redness at the injection site.  The patient treated the events with ibuprofen every four hours  and a warm compress beginning on 01-Jan-2021.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events soreness at the injection site, pain at the injection site, and redness at the injection site were not reported.  Reporter causality for the events was not provided.; Reporter'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.
Acute allergic reaction (hives and wheezing) 2-3 hours after shots. Admitted to hospital for steroids, Benadryl and albuterol nebulizer treatments. Also, had tried dairy (yogurt) for the 1st time, 20 minutes prior to allergic reaction.
Patient received the monovalent Pfizer COVID-19 vaccine as their booster dose instead of the intended bivalent Pfizer COVID-19 vaccine.
The day after the 3rd vaccine. I had a sore arm and a lot of fatigue. A low grade fever and stayed in bed all day. The next day I stayed in bed as well. Sunday I felt better. Two days after that I felt I had a low grade fever again and could not get out of bed. This lasted for about 3 or more days. I felt aches and pain.
Redness and swelling at injection site, fever, chills for 2 plus days. only local reaction remained on 10/26. No treatment.
Pt. seen at our clinic 6/30/17 for new onset rash in axilla and below breast. Went to urgent care 24 hrs later as rash progressed, eyelids, lips and ears were swelling. Also, C/O nausea. No trouble breathing, no vomiting. Given IV SOLU-MEDROL at urgent care. Discharged home on MEDROL dose pack, ranitidine, montelukast sodium. F/U w/PMD 7/3/17.
Lymphoma; This case was reported by a consumer via call center representative and described the occurrence of lymphoma in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 8th August 2019, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than 2 years after receiving Shingrix, the patient experienced lymphoma (serious criteria GSK medically significant). On an unknown date, the outcome of the lymphoma was unknown.   It was unknown if the reporter considered the lymphoma to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The patient was diagnosed with lymphoma after receiving vaccine. The reporter consented to follow up. All information was not available.
30 minutes after receiving both vaccines, the patient reported chest burning and nuasea. Shortly after she reported chest pain and throat closing. She went to the urgent care in the same building as the clinic and received treatment. She states she was told she had an allergic reaction to the vaccines and to take aspirin 325 three times daily by the physician as her discharge instructions.
Large rash on arm that immunization was given in.  Possible rash near eye (unknown if shingles).
the redness seems to be moving down my arm 4-5 inches from the injection; it's warm to the touch; injection site was sore; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (injection site was sore), VACCINATION SITE ERYTHEMA (the redness seems to be moving down my arm 4-5 inches from the injection) and VACCINATION SITE WARMTH (it's warm to the touch) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, the patient experienced INJECTION SITE PAIN (injection site was sore). On 04-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (the redness seems to be moving down my arm 4-5 inches from the injection) and VACCINATION SITE WARMTH (it's warm to the touch). At the time of the report, INJECTION SITE PAIN (injection site was sore), VACCINATION SITE ERYTHEMA (the redness seems to be moving down my arm 4-5 inches from the injection) and VACCINATION SITE WARMTH (it's warm to the touch) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The entire reddened area has moved down about 4-5 inches from the injection site. It's oblong in shape, but about the circumference of an orange and it's warm to the touch. Concomitant medication information not provided. Treatment information not provided.
patient was given monovalent Pfizer 6mo-<5yr for the 3rd dose instead of Pfizer bivalent 6mo-<5yr.  No treatment needed Parents were notified that monovalent dose was given instead of bivalent
the patients were getting scheduled too early; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a unspecified number of patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX).   On an unknown date, the patients received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patients experienced drug dose administration interval too short (Verbatim: the patients were getting scheduled too early). The outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK Receipt date: 03-AUG-2023 The reporter reported that their facility used a scheduling system to schedule Shingrix 2nd dose appointments, but there was a malfunction, and the patients were getting schedule too early. The reporter reported that few patients received second dose one month after the first dose. The reporter was unsure of how many patients were affected, but he knows at least two patients. The reporter did not have any patient information, dates of administration, or lot numbers available at time of call. The vaccine administration facility was the same as primary reporter. The reporter did consent to follow up. The reporter reported that the time interval between the first and second dose of Shingrix vaccine was less than 2 months, which led to shortening of vaccination schedule.
Severe chest pain similar to heart attack then 20 hours later shingles reappeared on back.
Swelling of the face and eyes treated with a steroid shot an loss of movement of both hands