chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Minimal pain on the injection Site After First Shot; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (Minimal pain on the injection Site After First Shot) in a 90-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Stent placement (Patient has a heart stent.).    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced INJECTION SITE PAIN (Minimal pain on the injection Site After First Shot). On 12-Feb-2021, INJECTION SITE PAIN (Minimal pain on the injection Site After First Shot) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-081727 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-081727:For second dose
can't sleep; muscle aches ("I can't walk , I can't sleep, it hurts so bad"); crippling; A spontaneous report  was received from a 79-years-old female consumer who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events muscle aches (i can't walk , i can't sleep, it hurts so bad), insomnia, and crippling.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 16 Feb 2021, prior to the onset of the events the consumer received first of two planned doses of mRNA-1273 (lot/batch: 006M20A) intramuscularly for prophylaxis of COVID-19 infection.  On 26 Feb 2021, ten days after the vaccination, the patient experienced the events muscle aches (i can't walk , i can't sleep, it hurts so bad) and crippling.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events, muscle aches (i can't walk, i can't sleep, it hurts so bad), insomnia, and crippling was not recovered / not resolved.; 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.
Covid arm.  Raised red itchy bump about 2 inches around.  Only sore when I press on it.
Swollen, painful underarm lymph node. At its worst about the size of a golf ball. Still slightly swollen and still painful 6 weeks later.
Itching at medial surface of left upper arm (injection site on lateral L UE). Also reported numbness down ventral surface of L forearm into hand. No weakness. She received Benadryl 50mg po at 10:00am. Itching began to improve during this documentation. No airway compromise. Clear mental status. She is recovering from the itching, but the  numbness in the hand is still present.
Patient had his first dose on 3/6/21 of Moderna vaccine.  He was scheduled 4/6/21 but attended another immunization clinic and marked his screening form as not having received vaccine before.
This spontaneous report as received from a certified medical assistant refers to an unspecified number of patients of unknown age and gender. Concurrent conditions and medical history were not reported. On an unknown date, the patients were vaccinated with doses of PROQUAD (Lot # reported as L010143, expiration date 24-SEP-2016; Lot # L008356, expiration date 11-SEP-2016) (Route and dose were not provided), which had temperature excursion. Concomitant medication was not reported. No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
N17.9 - Acute kidney failure, unspecified Acute pancreatitis abnormal CT  UTI Flank pain muscular chest pain chronic blood loss anemia upper GI bleed
had a reaction to that one, I had hives; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), in Apr2022 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: URTICARIA (non-serious), outcome "unknown", described as "had a reaction to that one, I had hives".  Additional information: Caller already had the Pfizer Bivalent vaccine and wanted to know if the Pfizer booster contains Sucrose. Caller would like to know the function of TRIS and sucrose. Caller would also like to know if the new COVID-19 vaccine 2023-2024 and the previous formulations of the COVID-19 vaccine also contained TRIS-sucrose.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
Felt wEak Faint After Standing up FElt NausEa After 10 miN. BP + PulsE StablE Lying down gave water FElt  bEttER After 20 min
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In or about June 2013, the patient was inoculated with ZOSTAVAX at a family health center as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. The patient was treated at the same family health center for a blistering vesicular outbreak that was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX, and/or despite receiving ZOSTAVAX for the long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
She could not lay on the arm (upper arm like below the shoulder), she could not put a pillow up on it; When she wanted to lift it, she could only lift it from my sides to 45 degrees; It was getting swell; she was tired so she took a nap; She didn't feel anything except that little sting that she said that would have; This is a spontaneous report from a contactable consumer (patient).   A 55-year-old female patient (height: 175 cm) received the first dose of pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) at single dose, on an unspecified date, at about 10:15 this morning, for immunization. Relevant medical history was none. Concomitant medications included flu shot (unspecified medication). Patient specified that she got a flu shot (Unspecified medication) in her right arm and pneumococcal 13-val conj vac (dipht crm197 protein) in her left. The patient stated that, on an unspecified date, she could not lay on the arm (upper arm like below the shoulder), she could not put a pillow up on it. When she wanted to lift it, she could only lift it from my sides to 45 degrees. It was getting swell and she was tired so she took a nap. She didn't feel anything except that little sting that she said that would have. Clinical outcome of the adverse events was unknown at time of this report.   No follow up attempts are needed. Information about lot/batch number cannot be obtained.
Dizziness, HYPERtension,  flushing, tingling on one side of the body- opposite side from injection Narrative:  dizziness, tingling, flushing, on left side of head down to left foot immediately after injection at 1148. BP increased to 168/104 with HR of 103 at 1211.
This case was reported by a other health professional via sales rep and described the occurrence of spot pigmented in a infant patient who received HIBERIX. On an unknown date, the patient received HIBERIX (intramuscular) .5 ml. On an unknown date, less than a year after receiving HIBERIX, the patient experienced spot pigmented. On an unknown date, the outcome of the spot pigmented was unknown. The reporter considered the spot pigmented to be probably related to HIBERIX. Additional details were provided as follows. This case was reported by Medical Assistant. The age at vaccination was not reported. The patient received HIBERIX in unknown thigh. It was reported that, 2 months after receiving HIBERIX, the patient returned with a black mark on thigh that they attributed to HIBERIX. The spot was looking a black tattoo, not like a blood blister or a bruise. It was unknown whether this office purchased this vaccine with private or public funds. The lot and expiration date of the vaccine was not known. The gender or age or date of birth was not provided. It was not known what other vaccines may have been administered at the same time for these two patients. This case has been linked with case US2017101776, reported by the same reporter for potentially siblings.
This spontaneous report was received from a physician via a company representative concerning to a patient of unknown age and gender. No concurrent conditions, medical history or concomitant medication were reported. On 03-SEP-2015, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 with lot # L007720 Expiration date: 08-JUL-2018, 0.5 ml (route and anatomical location of administration were not reported). The sum of hours in excursion was 72 hours and the lowest recorded temperature reported was 33 Fahrenheit (F) (0.555555556 Celsius (C)). The storage criteria and the storage type were reported as "Refrigerator(R)". The vaccine status was reported as "in excursion". No adverse effects were reported nor Product Quality Complaint (PQC) was involved. This is one of several cases received from the same reporter. Additional information has been requested.
No ADR, timing ERROR, 2nd dose given 47 days after 1st dose. Narrative:  No ADR, timing ERROR, 2nd dose given 47 days after 1st dose.
Patient reports swelling and pain at the injection site greater than what is to be expected. Patient has been managing these symptoms with anti-inflammatory medications and is to see his primary Wednesday for an appointment. Patient states the reaction started shortly after receiving the vaccine and that the pain has not significantly improved.
pt recvd vax; apnea episode after x3 w/cyanosis; EEG nl;
Sore arm day one and two. Day 4 Dizzy and Nauseous .  Day 8 Vertigo, tinnitus, dizziness, head ache, pressure in ears, achy joints specifically cervical spine.  Treating with advil and antihistamine. Went to PT for help with Vertigo and neck pain (did not help).  Did a hearing test so I could see an ENT - came back normal.  Day 15 went to ER Dizziness and Vertigo, cervical pain/tenderness so bad I couldn't walk, pressure in head, head ache.  MRI, EKG and Labs  all normal.   Dizziness a bit better on day 21 but still vertigo and mild tinnitus. I could walk but still could not work or drive. Appt with ENT next week.  Taking Turmeric, Vit C. D and B12, Advil, reduced movement, sleeping upright, and starting some vestibular and balance exercises form PT.  Vertigo still present when I bend down, roll over in bed or turn quickly, head and inner ears still feel full, brain fog and pain and achyiness in neck.  It is not day 28.  I've been advised to push out the 2nd vaccine
Patient received 2nd dose of the primary series of the COVID-19 Moderna vaccine a week early. Patient was monitored for 15-20 minutes and had no visible reactions nor did they report side effects/reactions. Patients stood up and walked out the clinic without complaints. Patient was notified of the incident via phone call, but did not answer. A voicemail was left explaining what occurred and the patient was told to return the call to answer any questions she may have had. Patient has not returned call.
Severe muscle ache, joint pain, 101.3 fever, headache, fatigue, dizziness
Overnight Sunday into Monday (July 18/19 2021) I started having contractions and it lasted overnight. I went to the hospital around 7AM and was 2CM dilated and 100% effaced upon arrival. I was admitted and had her at 2:48PM on the 19th Of July this year. She was born at 33weeks and 2 days, she was 7 weeks premature. Other than that, everything was fine, she was just early and did not have any complications or medical conditions at all. Pregnancy history is uneventful, I was not on any restrictions at all. My Due date was to be Sept 22 of 2021. It was a pretty uneventful pregnancy up until the premature labor. Her birth weight was 4.8 pounds.
I have two booster; I got sick; This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (I have two booster; I got sick) in a 68-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 056M21A) for COVID-19 prophylaxis.     Concurrent medical conditions included Asthma. Concomitant products included FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR) for Asthma, LAMOTRIGINE for an unknown indication.   On 16-May-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. 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 ILLNESS (I have two booster; I got sick). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) on 30-May-2022 for COVID-19 treatment, at a dose of 3 tablets for 5 days. At the time of the report, ILLNESS (I have two booster; I got sick) outcome was unknown.    Patient took two booster Moderna Covid-19 vaccine, and got sick, they put patient on Paxlovid. Patient seems to work fine about five days after finishing Paxlovid. Patient started getting like cold symptoms and that was about two days ago cold symptoms, yellow sputum which is now turning more clear and patient took a covid test and it was positive so, patient think he had rebound covid. Symptoms reported by patient as very very tired. Patient further stated that patient was not experiencing side effect because of the vaccination it was due to Paxlovid. Patient was taking cold medications, herbal cold medications because he thought he had cold when one's he finished Paxlovid and symptoms came back like cold but today he tested positive for covid." When probed if adverse events are worsening, improved and persisting. Patient stated, "No well he don't if it is a covid rebound is a side effect of Paxlovid.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Upon internal review on 05-July-2022, significant correction was performed. Moderna vaccine was removed from historical vaccine and added in product tab. Removed the classification of Tracking only.
I had a pulmonary embolism on 01/13/2023. I went to the hospital where all kinds of tests were done such as CT scans performed on 01/13/2023. I have recovered from my symptoms today. I stayed two days at the hospital for observation.
Covid Arm: treated with an antibiotic, as the term Covid Arm was not know at the time; last 1 week after beginning the antibiotic
Febrile seizure in am after finishing half portion of baby food. Sudden color change and seizure activity in upper arms and hands, with vomiting. Seizure lasted approx 15 min. Pt continued to drool. Cried all during the night on 1/27/10. Fever in am. Brought to ER by paramedics/ambulance.
48 hours after I received the first Moderna Covid vaccine, I got red raised blotches on my right hand and near the crook of my left arm. Over the course of the week the spots began to burn and tingle developed blisters. My doctor did not know what it could have been but prescribed a steroid cream for treatment. I used it twice a day for the past 3 days and the rash has stayed the same currently.
Left arm burning for the first 30 minutes after injection ,  than burning stopped . intermittent nausea for a couple of hours.  Low grade fever 100.2  (resolved with Tylenol) Moderate to severe joint and muscle pain that?s continues 20 hours after receiving injection .  Will give another 24 hours before seeing a physician.
he got weals; Pain; fell very ill; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of wheals in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced wheals (Verbatim: he got weals), pain (Verbatim: Pain) and illness (Verbatim: fell very ill). The outcome of the wheals, pain and illness were not reported.   It was unknown if the reporter considered the wheals, pain and illness to be related to Shingles vaccine.     It was unknown if the company considered the wheals, pain and illness to be related to Shingles vaccine.   Additional Information: GSK receipt date: 22-JUN-2023 The case was received from the consumer interactive digital media. The reporter stated that someone told him/her that he had been at the hospital and that he had been given the vaccine and that he fell very ill, he got wheals and that the pain was unbearable and in fact he told that reporter should never get this vaccine done, that's why reporter had the doubt.   The follow-up could not be possible as no contact details were available.
Fever of 102.3 since 4:30 pm 5-16-07, 101.6 5-16-07. Bruising at site of injections.
Tingling in lips 40 minutes after the vaccination. Tingling went away after 5-10 minutes.
Pt exhibited pale skin, with uneasy gait. Pt sat down in chair. Pt complained of nausea and light headedness. Pt requested water. Approximately 4min after receiving vaccines, proceeded to vomit. 30 min after vaccination, pt stated he was feeling 'good'.
Patient stated she had numbness in arm and tightness in fingers, she was instructed to see the physician immediately. She came to report that they gave her prednisone and naproxen at the ER and believe she had an allergic reaction and advised her not to get the 2nd dose.
Pt recv vax on 8/13/98; on 8/14/98 pt exp red/ hot/ knot/ sore vax site
increase pain in stomach and intestine also increase spread of nephropathy from feet to lower legs and forearms and hands
Mania, confusion, insomnia, dry mouth, headache within 3 hours of vaccine.  Improved within 18-hours.
Patient fainted in the elevator on his way out of the office and hit his head on the handrail as he fell in the elevator, as reported.
Pt received proquad inadvertently when was not due for Varicella. Just received Varicella on 1/6/2023
30 mins p/leaving clinic, returned to clinic stated pt became blue, shaking noted pt to be pale, dusky, jittery, hypertonic sent to ER; no MD on site;
Drop in blood pressure, trouble breathing, cough, numb and tingling cold hands, headache, seeing black spots, feeling light headed.  Started a few minutes after vaccination, needed to sit with feet elevated, lasted an hour and needed with falling asleep like narcoleptic.
had Covid in Dec2021; had Covid in Dec2021; This is a spontaneous report received from contactable reporter(s) (Nurse) from medical information team.  A 16-year-old male patient received BNT162b2 (BNT162B2), on 16May2021 as dose 1, single (Lot number: EW0183) and on 07Jun2021 as dose 2, single (Lot number: EW0186) at the age of 16 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Dec2021, outcome "unknown" and all described as "had Covid in Dec2021". The patient underwent the following laboratory tests and procedures: COVID-19: (Dec2021) Positive, notes: Had Covid-19 around in Dec2021 around Christmas.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal association between the events and suspect drug BNT162B2 cannot be excluded.
I had a bad reaction to my second moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (I had a bad reaction to my second moderna vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE REACTION (I had a bad reaction to my second moderna vaccine). At the time of the report, VACCINATION SITE REACTION (I had a bad reaction to my second moderna vaccine) outcome was unknown.            Concomitant product use was not provided by the reporter.  No treatment information was provided.
left knee was extremely sore; i can barely walk; This is a spontaneous report from a contactable consumer or other non hcp the patient reported.  A 55-years-old male patient received bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration on an unspecified date as dose 2, single for covid-19 immunisation. Historical vaccine, the patient took first dose bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced, since 11 days of second shot it worsened every morning when he woke up and he could barely walk and his left knee was extremely sore. The outcome of the events was not recovered.   No follow-up attempts are needed. information about lot/batch number cannot be obtained.
At 10:25 a.m. patient had c/o difficulty breathing.  BP: 144/89 Sats: 95-100% P:75-100 At 10:30 EMS on scene. BP: 146/98 P: 60 Sats: 97%
DIZZINESS, SORE ARM X 24 HOURS POST INJECTION Narrative:
Per patient, bleeding at the injection site immediately after administration. Bleeding controlled with band-aid. Arm soreness developed about 2 hours after administration. Next day patient noticed knot at injection site, soreness and warm to the touch. Patient did not seek medical attention. Soreness lasted several days, 6 days after vaccine, patient developed red itchy rash at injection site. Self treated with OTC Benadryl and symptoms resolved. Arm soreness lasted about 9 days. Patient called clinic to report side effects.