chrisvoncsefalvay/vaers-outcomes huggingface dataset:
From shoulder to just above elbow on injection site arm was severely swollen, dark red, hot and hard, and burned and stung but did not itch. Neck, shoulder and upper back pain moderate, joint aches and stiffness moderate, severe headache, moderate chills, dizziness, and fever the prior night (10-14-08) to the point of hallucinating and sweating severely  (temp not recorded). Aches, pain, headache, fever and dizziness throughout 10-15-08. Went to ER at 9:30 pm on 10-15-08. ER doc stated he had seen other cases like this and administered 25 mgs of Benadryll and an ice pack and a precautionary RX of Bactrim but told not to fill unless family doctor recommended it. Swelling went down by morning of 10-16-08 a little bit with repeated ice applications and 37.5 mgs of Benadryll the previous night, but still significantly red just below injection site. Called Family Doctor to let them know and to get Lot#'s and information. My mother has had flu and a Pneumonia injections previously with no adverse reactions at all, not even aches or pains.
Site: Itching at Injection Site-Mild, Systemic: Allergic: Itch Generalized-Mild, Additional Details: itching that developed 4 days after shot- no rash no other symptoms
it is tender in the whole arm from shoulder to elbow; My left foot is having a feeling of very hotness / It feels like putting my foot in a hot bath / My left foot and my left ankle are very hot / It is similar to when they give you Iodine in a CT scan / it is localized in ankle and foot; I experienced a reaction that was strange / But to the touch I don't feel it hot, it feels cold with my touch; Pretty painful, felt like being hit by a baseball bat / lingering pain; I experienced a reaction in my arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pretty painful, felt like being hit by a baseball bat / lingering pain), VACCINATION SITE REACTION (I experienced a reaction in my arm), FEELING HOT (My left foot is having a feeling of very hotness / It feels like putting my foot in a hot bath / My left foot and my left ankle are very hot / It is similar to when they give you Iodine in a CT scan / it is localized in ankle and foot), FEELING OF BODY TEMPERATURE CHANGE (I experienced a reaction that was strange / But to the touch I don't feel it hot, it feels cold with my touch) and TENDERNESS (it is tender in the whole arm from shoulder to elbow) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 078C21A) for COVID-19 vaccination.     Concomitant products included DROSPIRENONE for an unknown indication.    On 04-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Aug-2021, the patient experienced PAIN (Pretty painful, felt like being hit by a baseball bat / lingering pain) and VACCINATION SITE REACTION (I experienced a reaction in my arm). On 05-Aug-2021, the patient experienced FEELING HOT (My left foot is having a feeling of very hotness / It feels like putting my foot in a hot bath / My left foot and my left ankle are very hot / It is similar to when they give you Iodine in a CT scan / it is localized in ankle and foot) and FEELING OF BODY TEMPERATURE CHANGE (I experienced a reaction that was strange / But to the touch I don't feel it hot, it feels cold with my touch). On an unknown date, the patient experienced TENDERNESS (it is tender in the whole arm from shoulder to elbow). At the time of the report, PAIN (Pretty painful, felt like being hit by a baseball bat / lingering pain), VACCINATION SITE REACTION (I experienced a reaction in my arm), FEELING HOT (My left foot is having a feeling of very hotness / It feels like putting my foot in a hot bath / My left foot and my left ankle are very hot / It is similar to when they give you Iodine in a CT scan / it is localized in ankle and foot), FEELING OF BODY TEMPERATURE CHANGE (I experienced a reaction that was strange / But to the touch I don't feel it hot, it feels cold with my touch) and TENDERNESS (it is tender in the whole arm from shoulder to elbow) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information  was not provided.
Patient was in his usual state of health. On Wed, 4/7/21, at 10:20am, he received the first dose of Pfizer COVID-19 vaccine. No immediate vaccine reactions. He went home, complained of pain at the vaccination site and took a nap because he stayed up late the night before.  On Thursday morning, he woke up with chills and feeling like having a fever. He took Tylenol and then took a nap. On Thursday night, he began to have chest pain but he did not tell his parents.  On Friday, he continued to have chest pain so he told his parents about it. His father told him that if chest pain got worse, they would go to an ER. On that night (Friday) at 1am, he told his parents that he was not feeling well, his chest pain had gotten worse and he wanted to be taken to an ER. He also had abdominal pain, dizziness, disorientation, and he vomited. He was taken to ER where he was found to have elevated troponin of 10. The ER recommended  transferring for further work up and the father drove him to the hospital. At the hospital, he was found to have elevated troponins and NT-proBNP concerning for myocarditis of unclear etiology. He was monitored on telemetry and had no concerning ectopy. He had an echo on admission that demonstrated no structural abnormalities, trivial mitral valve regurge, and normal biventricular systolic function. EKG was unremarkable. Troponins were trended q6h and decreased from 32 -- > 23 -- > 17. NT-pro-BNP decreased from 439 to 322 at discharge.
L vision loss Narrative:  Vaccine administered on 2/12/21 at MC-- Pt developed L eye vision loss on 2/16/21 reported to ER, had CT head which was negative, his EKg was in NSR, he was sent to eye ER, where he was diagnosed with CRAO, pt was advised to get Echo and carotid doppler and to see at eye office on 2/26. Pt also instructed to follow-up with Cardiology
INTERFERED WITH ABILITY TO SLEEP; ITCHY RASH ON LEFT SIDE OF NECK, SPREAD UPWARDS TOWARD SCALP AND TOWARD LOWER ABDOMEN ABOVE PUBIC AREA AND ITCHED WHICH LOOK LIKE PINK SPLOTCHES; NAUSEA; TACHYCARDIA; This spontaneous report received from a patient concerned a 62 year old female. The patient's height, and weight were not reported. The patient's past medical history included stress-related lupus, and concurrent conditions included non-alcohol user, non-smoker, penicillin allergy, sulfa allergy, crohn's disease, and arthritis, and other pre-existing medical conditions included the patient have no history of drug abuse or illicit drug usage.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, expiry: UNKNOWN) dose was not reported, administered on 26-APR-2021 for prophylactic vaccination. Concomitant medications included paracetamol for arthritis. On 26-APR-2021, the subject experienced tachycardia. Laboratory data included: Heart rate (NR: not provided) usually 60 bpm increased as119bpm. On 27-APR-2021, the subject experienced nausea. On 28-APR-2021, the subject experienced interfered with ability to sleep. On 28-APR-2021, the subject experienced itchy rash on left side of neck, spread upwards toward scalp and toward lower abdomen above pubic area and itched which look like pink splotches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tachycardia on 27-APR-2021, and nausea on 28-APR-2021, had not recovered from itchy rash on left side of neck, spread upwards toward scalp and toward lower abdomen above pubic area and itched which look like pink splotches, and the outcome of interfered with ability to sleep was not reported. This report was non-serious.
Muscle aches,Migraine, night sweat; Muscle aches,Migraine, night sweat; Muscle aches,Migraine, night sweat; This is a spontaneous report from a contactable healthcare professional.  A 55-year-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), intramuscular on 16Dec2020 at 13:00 as single dose for COVID-19 immunization.  Medical history included fibromyalgia, degenerative bone disease from an unknown date.  The patient's concomitant medications were not reported.  No diagnosis of  COVID-19 was noted prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. There were no allergies to medications, food, or other products. The patient experienced muscle aches, migraine, night sweat on 16Dec2020, at  12:30, which was non-serious.  The outcome of muscle aches, migraine, night sweat  was recovered in Dec2020.  The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up .
Breakthrough case: I contracted COVID-19. My symptoms included: cough, headache, and fatigue for 3 to 4 days. I also had loss of smell.
SWELLING OF THE LYMPH NODES ON NECK ON THE SAME SIDE THE VACCINE WAS ADMINISTERED.  ALSO SWELLING OF THE FACE
Fairly severe adverse events started  around 3:30AM next morning with shaking chills, temp 102, headache, severe neck pain, nausea, generalized  myalgia and arthralgia, axillary tenderness radiating to left hand, profound fatique/malaise, anorexia,  and, of course, injection site swelling, redness, warmth and pain.   Fever continued to spike  at intervals over next 24 hours.  I was able to reduce fever with  ES tylenol  or Ibuprofen, put H/A , neck pain, arthralgia and myalgia were unrelieved, even with  hydrocodone /Apap 7.5/325.  In short, this was a miserable 24 hours.  I did not feel able to get out of bed until 10AM the following day.
Cellulitis; Welts/ welts on their arm; Swelling/ arm swelled up pretty big; allergic reaction; This case was reported by a pharmacist via call center representative and described the occurrence of cellulitis in a patient who received HAV (Havrix) for prophylaxis.   Concomitant products included PNEUMOCOCCAL VACCINE (PNEUMOVAX-23).   On 17th September 2019, the patient received Havrix. On an unknown date, less than a week after receiving Havrix, the patient experienced cellulitis (serious criteria GSK medically significant), welts, swelling arm and allergic reaction. On an unknown date, the outcome of the cellulitis, welts, swelling arm and allergic reaction were unknown.   It was unknown if the reporter considered the cellulitis, welts, swelling arm and allergic reaction to be related to Havrix.  Additional details were provided as follows: The age at vaccination not reported at time of report. The pharmacist gave a patient Pneumovax-23 and Havrix in the same arm, then the patient developed what sounds like an allergic reaction.  They had welts on their arm, cellulitis, and the arm swelled up pretty big. The patient's physician told them the reaction was due to bacteria build up because the vaccines were given in the same arm. The reporter stated that vaccines given in their own syringes in separate sites, but in the same arm.  The reporter gave the vaccines at a clinic she ran at the location indicated under vaccine facility details; however, she works out of the address for the contact profile. The reporter does not have any further information, she does not even know who the patient was at this time. Same information as passed along to her. The reporter was consented to follow up.
Patient was vaccinated with Pfizer #1 on 3/04/2021 (lot EN6205). He received a second invitation for vaccine in error, signed up, and was vaccinated a second time with Moderna  on 3/29/2021.  No adverse outcomes or symptoms reported;  counseled by doctor that this is not preferred but is acceptable and he will not need additional vaccine. Troubleshooting: This was missed in screening and the doctor acknowledged some complacency in the vaccinator who administered the shot.
Lower back pain ("kidney pain" ); ringing on the left ear (feels like there is air swishing inside); dizziness; severe throbbing headache/pressure; left arm (site of injection) became swollen; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of BACK PAIN (Lower back pain ("kidney pain" )), TINNITUS (ringing on the left ear (feels like there is air swishing inside)), DIZZINESS (dizziness), HEADACHE (severe throbbing headache/pressure) and VACCINATION SITE SWELLING (left arm (site of injection) became swollen) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in April 2020. Concurrent medical conditions included Low back pain in May 2020.    On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Apr-2021, the patient experienced BACK PAIN (Lower back pain ("kidney pain" )), TINNITUS (ringing on the left ear (feels like there is air swishing inside)), DIZZINESS (dizziness), HEADACHE (severe throbbing headache/pressure) and VACCINATION SITE SWELLING (left arm (site of injection) became swollen). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency; ASPIRIN [ACETYLSALICYLIC ACID] at an unspecified dose and frequency and MECLIZINE [MECLOZINE] at an unspecified dose and frequency. At the time of the report, BACK PAIN (Lower back pain ("kidney pain" )), TINNITUS (ringing on the left ear (feels like there is air swishing inside)), DIZZINESS (dizziness), HEADACHE (severe throbbing headache/pressure) and VACCINATION SITE SWELLING (left arm (site of injection) became swollen) had not resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported.  Treatment medication included, Aspirin, Tylenol. On 11Apr2021, she went to the emergency room and was given Toradol injection for the headache and Meclizine for the dizziness and Pseudo tripolidine.  Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable     This case was linked to MOD-2021-077669 (E2B Linked Report).; Sender's Comments:  MOD-2021-077669:First Dose
This spontaneous report as received from a Health care worker refers to a female patient of unknown age. On an unknown date the patient was vaccinated with ZOSTAVAX (lot# J014809, expiration date 20-FEB-2015), 0.65 ml, subcutaneous. One to two days post vaccination, the patient had reactions. It was reported that the patient developed severe rash from shoulder all the way down below the elbow of the vaccinated arm, with pain, swelling, and itching. The patient sought for medical attention by contacting office. The treatment given for the adverse event was reported as "over the counter BENADRYL and CLARITIN". The reporter stated she did not think it was shingles, since the patient recovered within one week time. This is one of several reports received from the same source. There were another 2 patient have the same reactions from the same lot number. Additional information has been requested.
blood on the bandaid/Bleeding; feel a little sore/Soreness; This is a spontaneous report from contactable consumers (included patient) via medical information team. A 20-year-old female patient received bnt162b2 (Solution for injection), via an unspecified route of administration, administered in Arm Left on 18May2021 (at the age of 20-year-old) (Lot Number: EW0177; Expiration Date: 21Aug2021) as 1ST DOSE, SINGLE DOSE for covid-19 immunisation. The patient had no history and concomitant medication. The patient had a quick concern and stated got vaccinated on 18May2021 (today) with first dose and she just looked up at her injection site little there was bit of blood, it was not bleeding but there was blood. On an unknown date in May2021, she had a little bit of blood on her bandage after she got the vaccine, but it was no longer bleeding. The patient did mention a little soreness on same date. Outcome of the events was unknown. Follow up attempts are needed. Further information has been requested.
weakness; fever of 102.4 degrees Fahrenheit; chills; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (weakness), CHILLS (chills), FATIGUE (fatigue) and PYREXIA (fever of 102.4 degrees Fahrenheit) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Apr-2021, the patient experienced CHILLS (chills) and FATIGUE (fatigue). On 20-Apr-2021, the patient experienced ASTHENIA (weakness) and PYREXIA (fever of 102.4 degrees Fahrenheit). At the time of the report, ASTHENIA (weakness), CHILLS (chills), FATIGUE (fatigue) and PYREXIA (fever of 102.4 degrees Fahrenheit) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported Treatment information was not provided
Got Shingles again; This case was reported by a lawyer and described the occurrence of shingles in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 25th September 2019, the patient received the 1st dose of Shingrix (intramuscular). On 21st January 2020, 118 days after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional information: The initial information received via legal complaint. As per the legal complaint on 25 September 2019 the plaintiff got first shot of shingrix, on 21 January 2020, 29 January 2020 and 01 March 2020 the plaintiff got shingles again. On 18 March 2020, the plaintiff got second shot of shingrix on 16 April 2020 and 22 May 2020, got shingles again. The patient was put on medicine for 6 months and had 10 *5 they talked into shots. The patient still got 6*5 for shot plus. The reporter thinks deserve money back after both doses.
This is a spontaneous report from a Pfizer sponsored program received from a non-contactable consumer (reporting for herself). A female patient of an unspecified age and ethnicity received PREVNAR 13, via an unspecified route of administration on 20Oct2017 at a single dose for pneumonia. The patient's medical history was and concomitant medications were not reported. On an unspecified date, the patient experienced rash underneath her breasts. They took biopsy and said it was contact dermatitis. The outcome of the events was unknown. No follow up attempts are possible. No further information is expected.
72 hours after injection severe abdominal rash, went to MD and was told it was related to vaccine
1147 am After blood draw and 2 immunizations patient became unable to sit up, incoherent and improper affect, laughing inappropriately, layed patient down. kept trying to get up, appeared out of it, gave gatorade and donut, shaking soon started, patient would be in and out of coherent speech, was able to identify where she was then she would shake and denied breathing issues or nausea, Bp glucose wnl, EMS called @ 11:58am and arrived @ 12:10, pt being transported to hospital by ems
This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information was provided regarding the patient's concurrent conditions, medical history or concomitant medications. On 16-NOV-2018, the patient was vaccinated with an expired dose of VAQTA lot # N026997 for prophylaxis (dose and route of administration were not reported). However, no adverse effects were reported.
Headache, Myalgia, Arthralgia, Nausea Vomiting,  fatigue
Menstruation came a week early. Started spotting on the 29th  & 30th. Period was not due until 9/3/21.
Patient reports:  "Writing you to let you know about my extreme reaction to the flu and pneumonia shots I got last Thursday. I don't know if this should be put in my records or not. I was fine for about 3 hours - then it felt like a train hit me. Chills that 5 blankets would not help, then so, so hot. That could have been caused by the 5 blankets I suppose. Then sick to my stomach. Then a little trouble breathing, then a feeling that my heart was beating a little too fast. When my head felt like it was going to explode, I screamed that I needed Tylenol. That slowly calmed all but the chills down. The next morning I was still quite weak. But got better as the day went on. By afternoon I was fine! Like I say, don't know if this should go in my records or not. I am perfectly fine now."
She had a sudden hot sensation come over her. She felt like she was going to pass out. She was dizzy- heart rate increased to 122,  nauseated and developed a very red rash all over her chest and face.  She was given 50mg of Benadryl.  She waited for an hour at the clinic and did not need to go to the ER.  Symptoms subsided.
Case number PHEH2014US003602, is an initial spontaneous report from a pharmacist received on 21 Feb 2014. This report refers to a patient of unknown gender and over 55 years of age. Past medical history and concomitant medications were not reported. The patient was inadvertently vaccinated with MENVEO (batch number: not reported) intramuscularly on undetermined date in Dec 2013. No adverse reactions had occurred since the maladministration (inappropriate age at vaccine administration).
Contacted Covid after their first vaccine; Contacted Covid after their first vaccine; This is a spontaneous report from a Pfizer sponsored program from a contactable consumer. The consumer reported similar events for two patients. This is the first of two reports. A patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose on an unspecified date for COVID-19 immunisation. Medical history and concomitant medication were not reported. Patient contacted COVID after their first vaccine. The outcome of events was unknown.  Information on lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021086942 the same reporter, product and similar adverse events in different patients
The product was refrigerated on 29-Oct-2021 beyond expiration date 13-Oct-2021; 606 doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (The product was refrigerated on 29-Oct-2021 beyond expiration date 13-Oct-2021) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The product was refrigerated on 29-Oct-2021 beyond expiration date 13-Oct-2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (The product was refrigerated on 29-Oct-2021 beyond expiration date 13-Oct-2021) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided.  Patient didn't reported any adverse events. The vials didn't undergo any temperature excursion. The vaccine was kept in the refrigerator on 29-Oct-2021.  No treatment information was provided.